Medical devices and IVDs: Suspensions from the ARTG

20 October 2017

Following a review by the TGA, medical devices (including IVDs) can be suspended from the Australian Register of Therapeutic Goods. These suspensions are made by the Secretary under section 41GA of the Therapeutic Goods Act 1989.

Medical devices and IVDs can also be suspended from the ARTG if the conformity assessment certificate applying to that kind of device is suspended under section 41GF.

If a suspension occurs because of a safety concern, the TGA considers whether other actions including a recall are necessary and takes those actions when required. Any related safety alerts will appear under 'Further information'.

The reasons for a suspension are stated in the database under 'Grounds for suspension'.

The heading 'Decision status' provides updated information about a suspension, for example, a decision to extend the suspension, or information about any decision to revoke a suspension decision. It will not appear in every entry.

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Sort by: Sponsor A-Z, Product A-Z, ARTG No, Suspension start date, Suspension end date

Philips Electronics Australia Ltd

Product name/ARTG reference:
IntelliVue MX40

ARTG No:
99204
Type of regulatory action:
Suspension from ARTG for a 6 month period under paragraph 41GA(1)(a)(i) of the Act
Suspension start date:

End date:

6 monthly suspension of the device under paragraph 41GA(1)(a)(i) of the Act due to the potential risk of death, serious illness or serious injury if the kind of device continues to be included in the ARTG.

Covidien/Medtronic Australasia Pty Ltd

Product name/ARTG reference:
Puritan Bennett 980 Series Ventilator

ARTG No:
221416
Type of regulatory action:
Suspension from ARTG for a 6 monthly period under paragraph 41GA(1)(a)(i) of the Act
Suspension start date:

6 monthly suspension of the device under paragraph 41GA(1)(a)(i) of the Act due to the potential risk of death, serious injury or illness if the kind of device continues to be included in the ARTG.

Endotherapeutics Pty Ltd

Product name/ARTG reference:
SerenoCem Granules BCG050

ARTG No:
152441
Type of regulatory action:
Suspension from the ARTG under s.41GA(1)(b)
Suspension start date:

Under subsection 41GA(1)(b); there is likely that there are grounds for cancelling this device from the ARTG under subsection GN(1)(b).

Further information

Suspension effective for 6 months. The suspension is limited to the SerenoCem Granules BCG050 only.

Thermo Fisher Scientific Australia Pty Ltd

Product name/ARTG reference:
QuickVue One-Step hCG urine test kit

ARTG No:
199827
Type of regulatory action:
Suspended from the ARTG under s.41GA(1)(b)
Suspension start date:

I am satisfied that the requirements of section 41GA of the Act have been met and that there are grounds for cancelling the entry under section 41GN(1)(b), due to the non-compliance with Essential Principles 3, 6, and 15.

Thermo Fisher Scientific Australia Pty Ltd

Product name/ARTG reference:
QuickVue One-Step hCG urine test kit

ARTG No:
254033
Type of regulatory action:
Suspended from the ARTG under s.41GA(1)(b)
Suspension start date:

I am satisfied that the requirements of section 41GA of the Act have been met and that there are grounds for cancelling the entry under section 41GN(1)(b), due to the non-compliance with Essential Principles 3, 6, and 15.

Australian Blood Management Unit Trust

Product name/ARTG reference:
Cardiopulmonary bypass system heating/cooling unit

ARTG No:
278698
Type of regulatory action:
Suspension from the ARTG under s.41GA(1)(b)
Suspension start date:

End date:

Under subsection 41GA(1)(b); there is likely that there are grounds for cancelling this kind of device from the ARTG under subsection GN(1)(b).

Further information

A decision to extend the suspension period for an additional 6 months was made in accordance with section 41GC of the Therapeutic Goods Act 1989.

Device Technologies

Product name/ARTG reference:
Device Technologies Australia Pty Ltd - Skin expander

ARTG No:
141293
Type of regulatory action:
Suspension from the ARTG under s.41GA (1)(b)
Suspension start date:

End date:

As the devices do not comply with Essential Principle 7.2 (1), the certifications made under s.41FD(d)are no longer correct. As this is grounds for cancellation of an ARTG entry under s. 41GN(1)(f) of the Act (and thus grounds for suspension), the Secretary has proposed to suspended the entries for a period not exceeding 6 months.

Further information

A website publication on medical devices manufactured by Silimed can be found at Silimed medical devices (all - including breast implants)

Device Technologies

Product name/ARTG reference:
Device Technologies Australia Pty Ltd - Tissue reconstructive material, synthetic, silicone, sheet

ARTG No:
143151
Type of regulatory action:
Suspension from the ARTG under s.41GA (1)(b)
Suspension start date:

End date:

As the devices do not comply with Essential Principle 7.2 (1), the certifications made under s.41FD(d)are no longer correct. As this is grounds for cancellation of an ARTG entry under s. 41GN(1)(f) of the Act (and thus grounds for suspension), the Secretary has proposed to suspended the entries for a period not exceeding 6 months.

Further information

A website publication on medical devices manufactured by Silimed can be found at Silimed medical devices (all - including breast implants)

Device Technologies

Product name/ARTG reference:
Device Technologies Australia Pty Ltd - Tissue reconstructive material, synthetic, silicone, block

ARTG No:
143152
Type of regulatory action:
Suspension from the ARTG under s.41GA (1)(b)
Suspension start date:

End date:

As the devices do not comply with Essential Principle 7.2 (1), the certifications made under s.41FD(d)are no longer correct. As this is grounds for cancellation of an ARTG entry under s. 41GN(1)(f) of the Act (and thus grounds for suspension), the Secretary has proposed to suspended the entries for a period not exceeding 6 months.

Further information

A website publication on medical devices manufactured by Silimed can be found at Silimed medical devices (all - including breast implants)

Device Technologies

Product name/ARTG reference:
Device Technologies Australia Pty Ltd - Prosthesis, internal, band, gastroplasty

ARTG No:
143181
Type of regulatory action:
Suspension from the ARTG under s.41GA (1)(b)
Suspension start date:

End date:

As the devices do not comply with Essential Principle 7.2 (1), the certifications made under s.41FD(d)are no longer correct. As this is grounds for cancellation of an ARTG entry under s. 41GN(1)(f) of the Act (and thus grounds for suspension), the Secretary has proposed to suspended the entries for a period not exceeding 6 months.

Further information

A website publication on medical devices manufactured by Silimed can be found at Silimed medical devices (all - including breast implants)

Device Technologies

Product name/ARTG reference:
Device Technologies Australia Pty Ltd - Balloon, gastric, appetite-suppressing

ARTG No:
143651
Type of regulatory action:
Suspension from the ARTG under s.41GA (1)(b)
Suspension start date:

End date:

As the devices do not comply with Essential Principle 7.2 (1), the certifications made under s.41FD(d)are no longer correct. As this is grounds for cancellation of an ARTG entry under s. 41GN(1)(f) of the Act (and thus grounds for suspension), the Secretary has proposed to suspended the entries for a period not exceeding 6 months.

Further information

A website publication on medical devices manufactured by Silimed can be found at Silimed medical devices (all - including breast implants)

Device Technologies

Product name/ARTG reference:
Device Technologies Australia Pty Ltd - Prosthesis, internal, testicle

ARTG No:
144004
Type of regulatory action:
Suspension from the ARTG under s.41GA (1)(b)
Suspension start date:

End date:

As the devices do not comply with Essential Principle 7.2 (1), the certifications made under s.41FD(d)are no longer correct. As this is grounds for cancellation of an ARTG entry under s. 41GN(1)(f) of the Act (and thus grounds for suspension), the Secretary has proposed to suspended the entries for a period not exceeding 6 months.

Further information

A website publication on medical devices manufactured by Silimed can be found at Silimed medical devices (all - including breast implants)

Device Technologies

Product name/ARTG reference:
Device Technologies Australia Pty Ltd - Prosthesis, internal, chin

ARTG No:
144268
Type of regulatory action:
Suspension from the ARTG under s.41GA (1)(b)
Suspension start date:

End date:

As the devices do not comply with Essential Principle 7.2 (1), the certifications made under s.41FD(d)are no longer correct. As this is grounds for cancellation of an ARTG entry under s. 41GN(1)(f) of the Act (and thus grounds for suspension), the Secretary has proposed to suspended the entries for a period not exceeding 6 months.

Further information

A website publication on medical devices manufactured by Silimed can be found at Silimed medical devices (all - including breast implants)

Device Technologies

Product name/ARTG reference:
Device Technologies Australia Pty Ltd - Prosthesis, internal, ear

ARTG No:
144269
Type of regulatory action:
Suspension from the ARTG under s.41GA (1)(b)
Suspension start date:

End date:

As the devices do not comply with Essential Principle 7.2 (1), the certifications made under s.41FD(d)are no longer correct. As this is grounds for cancellation of an ARTG entry under s. 41GN(1)(f) of the Act (and thus grounds for suspension), the Secretary has proposed to suspended the entries for a period not exceeding 6 months.

Further information

A website publication on medical devices manufactured by Silimed can be found at Silimed medical devices (all - including breast implants)

Device Technologies

Product name/ARTG reference:
Device Technologies Australia Pty Ltd - Prosthesis, internal, muscle

ARTG No:
144270
Type of regulatory action:
Suspension from the ARTG under s.41GA (1)(b)
Suspension start date:

End date:

As the devices do not comply with Essential Principle 7.2 (1), the certifications made under s.41FD(d)are no longer correct. As this is grounds for cancellation of an ARTG entry under s. 41GN(1)(f) of the Act (and thus grounds for suspension), the Secretary has proposed to suspended the entries for a period not exceeding 6 months.

Further information

A website publication on medical devices manufactured by Silimed can be found at Silimed medical devices (all - including breast implants)

Device Technologies

Product name/ARTG reference:
Device Technologies Australia Pty Ltd - Prosthesis, internal, muscle

ARTG No:
144271
Type of regulatory action:
Suspension from the ARTG under s.41GA (1)(b)
Suspension start date:

End date:

As the devices do not comply with Essential Principle 7.2 (1), the certifications made under s.41FD(d)are no longer correct. As this is grounds for cancellation of an ARTG entry under s. 41GN(1)(f) of the Act (and thus grounds for suspension), the Secretary has proposed to suspended the entries for a period not exceeding 6 months.

Further information

A website publication on medical devices manufactured by Silimed can be found at Silimed medical devices (all - including breast implants)

Device Technologies

Product name/ARTG reference:
Device Technologies Australia Pty Ltd - Prosthesis, internal, muscle

ARTG No:
144272
Type of regulatory action:
Suspension from the ARTG under s.41GA (1)(b)
Suspension start date:

End date:

As the devices do not comply with Essential Principle 7.2 (1), the certifications made under s.41FD(d)are no longer correct. As this is grounds for cancellation of an ARTG entry under s. 41GN(1)(f) of the Act (and thus grounds for suspension), the Secretary has proposed to suspended the entries for a period not exceeding 6 months.

Further information

A website publication on medical devices manufactured by Silimed can be found at Silimed medical devices (all - including breast implants)

Device Technologies

Product name/ARTG reference:
Device Technologies Australia Pty Ltd - Prosthesis, internal, nose

ARTG No:
144273
Type of regulatory action:
Suspension from the ARTG under s.41GA (1)(b)
Suspension start date:

End date:

As the devices do not comply with Essential Principle 7.2 (1), the certifications made under s.41FD(d)are no longer correct. As this is grounds for cancellation of an ARTG entry under s. 41GN(1)(f) of the Act (and thus grounds for suspension), the Secretary has proposed to suspended the entries for a period not exceeding 6 months.

Further information

A website publication on medical devices manufactured by Silimed can be found at Silimed medical devices (all - including breast implants)

Device Technologies

Product name/ARTG reference:
Device Technologies Australia Pty Ltd - Prosthesis, internal, zygomatic

ARTG No:
144274
Type of regulatory action:
Suspension from the ARTG under s.41GA (1)(b)
Suspension start date:

End date:

As the devices do not comply with Essential Principle 7.2 (1), the certifications made under s.41FD(d)are no longer correct. As this is grounds for cancellation of an ARTG entry under s. 41GN(1)(f) of the Act (and thus grounds for suspension), the Secretary has proposed to suspended the entries for a period not exceeding 6 months.

Further information

A website publication on medical devices manufactured by Silimed can be found at Silimed medical devices (all - including breast implants)

Device Technologies

Product name/ARTG reference:
Device Technologies Australia Pty Ltd - Prosthesis, internal, zygomatic

ARTG No:
144275
Type of regulatory action:
Suspension from the ARTG under s.41GA (1)(b)
Suspension start date:

End date:

As the devices do not comply with Essential Principle 7.2 (1), the certifications made under s.41FD(d)are no longer correct. As this is grounds for cancellation of an ARTG entry under s. 41GN(1)(f) of the Act (and thus grounds for suspension), the Secretary has proposed to suspended the entries for a period not exceeding 6 months.

Further information

A website publication on medical devices manufactured by Silimed can be found at Silimed medical devices (all - including breast implants)

Device Technologies

Product name/ARTG reference:
Device Technologies Australia Pty Ltd - Prosthesis, internal, urethral, sphincter

ARTG No:
144276
Type of regulatory action:
Suspension from the ARTG under s.41GA (1)(b)
Suspension start date:

End date:

As the devices do not comply with Essential Principle 7.2 (1), the certifications made under s.41FD(d)are no longer correct. As this is grounds for cancellation of an ARTG entry under s. 41GN(1)(f) of the Act (and thus grounds for suspension), the Secretary has proposed to suspended the entries for a period not exceeding 6 months.

Further information

A website publication on medical devices manufactured by Silimed can be found at Silimed medical devices (all - including breast implants)

Device Technologies

Product name/ARTG reference:
Device Technologies Australia Pty Ltd - Prosthesis, internal, penile, rod

ARTG No:
144278
Type of regulatory action:
Suspension from the ARTG under s.41GA (1)(b)
Suspension start date:

End date:

As the devices do not comply with Essential Principle 7.2 (1), the certifications made under s.41FD(d)are no longer correct. As this is grounds for cancellation of an ARTG entry under s. 41GN(1)(f) of the Act (and thus grounds for suspension), the Secretary has proposed to suspended the entries for a period not exceeding 6 months.

Further information

A website publication on medical devices manufactured by Silimed can be found at Silimed medical devices (all - including breast implants)

Device Technologies

Product name/ARTG reference:
Device Technologies Australia Pty Ltd - Prosthesis, internal, stent, vaginal

ARTG No:
144436
Type of regulatory action:
Suspension from the ARTG under s.41GA (1)(b)
Suspension start date:

End date:

As the devices do not comply with Essential Principle 7.2 (1), the certifications made under s.41FD(d)are no longer correct. As this is grounds for cancellation of an ARTG entry under s. 41GN(1)(f) of the Act (and thus grounds for suspension), the Secretary has proposed to suspended the entries for a period not exceeding 6 months.

Further information

A website publication on medical devices manufactured by Silimed can be found at Silimed medical devices (all - including breast implants)

Device Technologies

Product name/ARTG reference:
Device Technologies Australia Pty Ltd - Dressing, occlusive, silicone

ARTG No:
145286
Type of regulatory action:
Suspension from the ARTG under s.41GA (1)(b)
Suspension start date:

End date:

As the devices do not comply with Essential Principle 7.2 (1), the certifications made under s.41FD(d)are no longer correct. As this is grounds for cancellation of an ARTG entry under s. 41GN(1)(f) of the Act (and thus grounds for suspension), the Secretary has proposed to suspended the entries for a period not exceeding 6 months.

Further information

A website publication on medical devices manufactured by Silimed can be found at Silimed medical devices (all - including breast implants)

Device Technologies

Product name/ARTG reference:
Device Technologies Australia Pty Ltd - Prosthesis, internal, joint, digit

ARTG No:
147758
Type of regulatory action:
Suspension from the ARTG under s.41GA (1)(b)
Suspension start date:

End date:

As the devices do not comply with Essential Principle 7.2 (1), the certifications made under s.41FD(d)are no longer correct. As this is grounds for cancellation of an ARTG entry under s. 41GN(1)(f) of the Act (and thus grounds for suspension), the Secretary has proposed to suspended the entries for a period not exceeding 6 months.

Further information

A website publication on medical devices manufactured by Silimed can be found at Silimed medical devices (all - including breast implants)

Device Technologies

Product name/ARTG reference:
Device Technologies Australia Pty Ltd - Prosthesis, internal, tendon sheath

ARTG No:
147759
Type of regulatory action:
Suspension from the ARTG under s.41GA (1)(b)
Suspension start date:

End date:

As the devices do not comply with Essential Principle 7.2 (1), the certifications made under s.41FD(d)are no longer correct. As this is grounds for cancellation of an ARTG entry under s. 41GN(1)(f) of the Act (and thus grounds for suspension), the Secretary has proposed to suspended the entries for a period not exceeding 6 months.

Further information

A website publication on medical devices manufactured by Silimed can be found at Silimed medical devices (all - including breast implants)

Device Technologies

Product name/ARTG reference:
Device Technologies Australia Pty Ltd - Mammary Implant - Silicone Gel - Textured Surface - Prosthesis, internal, mammary, gel filled

ARTG No:
148763
Type of regulatory action:
Suspension from the ARTG under s.41GA (1)(b)
Suspension start date:

End date:

As the devices do not comply with Essential Principle 7.2 (1), the certifications made under s.41FD(d)are no longer correct. As this is grounds for cancellation of an ARTG entry under s. 41GN(1)(f) of the Act (and thus grounds for suspension), the Secretary has proposed to suspended the entries for a period not exceeding 6 months.

Further information

A website publication on medical devices manufactured by Silimed can be found at Silimed medical devices (all - including breast implants)

Device Technologies

Product name/ARTG reference:
Device Technologies Australia Pty Ltd - Mammary Implant-Silicone Gel-Smooth Surface - Prosthesis, internal, mammary, gel filled

ARTG No:
148764
Type of regulatory action:
Suspension from the ARTG under s.41GA (1)(b)
Suspension start date:

End date:

As the devices do not comply with Essential Principle 7.2 (1), the certifications made under s.41FD(d)are no longer correct. As this is grounds for cancellation of an ARTG entry under s. 41GN(1)(f) of the Act (and thus grounds for suspension), the Secretary has proposed to suspended the entries for a period not exceeding 6 months.

Further information

A website publication on medical devices manufactured by Silimed can be found at Silimed medical devices (all - including breast implants)

Device Technologies

Product name/ARTG reference:
Device Technologies Australia Pty Ltd - Mammary Implant-Silicone Gel-Polyurethane Foam Coated - Prosthesis, internal, mammary, gel filled

ARTG No:
148765
Type of regulatory action:
Suspension from the ARTG under s.41GA (1)(b)
Suspension start date:

End date:

As the devices do not comply with Essential Principle 7.2 (1), the certifications made under s.41FD(d)are no longer correct. As this is grounds for cancellation of an ARTG entry under s. 41GN(1)(f) of the Act (and thus grounds for suspension), the Secretary has proposed to suspended the entries for a period not exceeding 6 months.

Further information

A website publication on medical devices manufactured by Silimed can be found at Silimed medical devices (all - including breast implants)

Device Technologies

Product name/ARTG reference:
Device Technologies Australia Pty Ltd - Catheter, urological, coude

ARTG No:
149172
Type of regulatory action:
Suspension from the ARTG under s.41GA (1)(b)
Suspension start date:

End date:

As the devices do not comply with Essential Principle 7.2 (1), the certifications made under s.41FD(d)are no longer correct. As this is grounds for cancellation of an ARTG entry under s. 41GN(1)(f) of the Act (and thus grounds for suspension), the Secretary has proposed to suspended the entries for a period not exceeding 6 months.

Further information

A website publication on medical devices manufactured by Silimed can be found at Silimed medical devices (all - including breast implants)

Device Technologies

Product name/ARTG reference:
Device Technologies Australia Pty Ltd - Sizer, mammary prosthesis

ARTG No:
149275
Type of regulatory action:
Suspension from the ARTG under s.41GA (1)(b)
Suspension start date:

End date:

As the devices do not comply with Essential Principle 7.2 (1), the certifications made under s.41FD(d)are no longer correct. As this is grounds for cancellation of an ARTG entry under s. 41GN(1)(f) of the Act (and thus grounds for suspension), the Secretary has proposed to suspended the entries for a period not exceeding 6 months.

Further information

A website publication on medical devices manufactured by Silimed can be found at Silimed medical devices (all - including breast implants)

Device Technologies

Product name/ARTG reference:
Device Technologies Australia Pty Ltd - Prosthesis, internal, bladder, urinary, mesh

ARTG No:
150019
Type of regulatory action:
Suspension from the ARTG under s.41GA (1)(b)
Suspension start date:

End date:

As the devices do not comply with Essential Principle 7.2 (1), the certifications made under s.41FD(d)are no longer correct. As this is grounds for cancellation of an ARTG entry under s. 41GN(1)(f) of the Act (and thus grounds for suspension), the Secretary has proposed to suspended the entries for a period not exceeding 6 months.

Further information

A website publication on medical devices manufactured by Silimed can be found at Silimed medical devices (all - including breast implants)

Lovell Surgical Supplies International Pty Ltd

Product name/ARTG reference:
Cardiopulmonary bypass system heating/cooling unit

ARTG No:
262576
Type of regulatory action:
Suspension from the ARTG under s.41GA(1)(b)
Suspension start date:

End date:

Under subsection 41GA(1)(b); there is likely that there are grounds for cancelling this kind of device from the ARTG under subsection 41GN(1)(b).

Medical Vision Australia Plastic & Cosmetic Pty Ltd

Product name/ARTG reference:
Cereform Silicone Gel-Filled Breast Implant (Smooth Texture)

ARTG No:
165460
Type of regulatory action:
Suspended from the ARTG under s. 41GA(1)(b) of the Act
Suspension start date:

End date:

As these devices do not comply with Essential Principle 8.3(3), the certification made under s.41FD(d) is no longer correct. As this is grounds for cancellation of an ARTG entry under s. 41GN(1)(f) of the Act (and thus grounds for suspension), the Secretary has suspended the entries for a period not exceeding 6 months.

Further information

This product was cancelled from the ARTG at the request of the sponsor effective on 29 October 2014. Further information about the devices is available in a related safety alert.

Medical Vision Australia Plastic & Cosmetic Pty Ltd

Product name/ARTG reference:
Cereform Silicone Gel-Filled Breast Implant (Intermediate Texture)

ARTG No:
165461
Type of regulatory action:
Suspended from the ARTG under s. 41GA(1)(b) of the Act
Suspension start date:

End date:

As these devices do not comply with Essential Principle 8.3(3), the certification made under s.41FD(d) is no longer correct. As this is grounds for cancellation of an ARTG entry under s. 41GN(1)(f) of the Act (and thus grounds for suspension), the Secretary has suspended the entries for a period not exceeding 6 months.

Further information

This product was cancelled from the ARTG at the request of the sponsor effective on 29 October 2014. Further information about the devices is available in a related safety alert.

Medical Vision Australia Plastic & Cosmetic Pty Ltd

Product name/ARTG reference:
Cereform Optima Silicone Gel-Filled Breast Implant

ARTG No:
165462
Type of regulatory action:
Suspended from the ARTG under s. 41GA(1)(b) of the Act
Suspension start date:

End date:

As these devices do not comply with Essential Principle 8.3(3), the certification made under s.41FD(d) is no longer correct. As this is grounds for cancellation of an ARTG entry under s. 41GN(1)(f) of the Act (and thus grounds for suspension), the Secretary has suspended the entries for a period not exceeding 6 months.

Further information

This product was cancelled from the ARTG at the request of the sponsor effective on 29 October 2014. Further information about the devices is available in a related safety alert.

Medical Vision Australia Plastic & Cosmetic Pty Ltd

Product name/ARTG reference:
Sizer, mammary prosthesi

ARTG No:
162029
Type of regulatory action:
Suspended from the ARTG under s. 41GA(1)(b) of the Act
Suspension start date:

End date:

As these devices do not comply with Essential Principle 8.3(3), the certification made under s.41FD(d) is no longer correct. As this is grounds for cancellation of an ARTG entry under s. 41GN(1)(f) of the Act (and thus grounds for suspension), the Secretary has suspended the entries for a period not exceeding 6 months.

Further information

This product was cancelled from the ARTG at the request of the sponsor effective on 29 October 2014. Further information about the devices is available in a related safety alert.