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Medical devices and IVDs: Suspensions from the ARTG

14 November 2019

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.

Medical devices and IVD suspensions

Displaying 26 - 50 of 64

2017

Suspension start date: 3 Oct 2017

Suspension end date: 3 Apr 2018

AA-Med Pty Ltd

Product name/ARTG reference: Derivo Embolisation Device with tip

ARTG number: 281030

Type of regulatory action: Suspension from the ARTG under s.41GA(1)(b)

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).

Further information:

Suspension effective for 6 months

Suspension start date: 3 Oct 2017

Suspension end date: 3 Apr 2018

AA-Med Pty Ltd

Product name/ARTG reference: Derivo Emobolisation Device w/out tip

ARTG number: 281033

Type of regulatory action: Suspension from the ARTG under s.41GA(1)(b)

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).

Further information:

Suspension effective for 6 months

Suspension start date: 14 Sep 2017

Suspension end date: 5 Feb 2018

Covidien/Medtronic Australasia Pty Ltd

Product name/ARTG reference: Puritan Bennett 980 Series Ventilator

ARTG number: 221416

Type of regulatory action: Suspension from ARTG for a 6 monthly period under paragraph 41GA(1)(a)(i) of the Act

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.

Further information:

The Minister has revoked the suspension and substituted another decision following a review of the Secretary's decision under section 60 of the Therapeutic Goods Act 1989. See further information above.

Suspension start date: 31 Aug 2017

Suspension end date:

Endotherapeutics Pty Ltd

Product name/ARTG reference: SerenoCem Granules BCG050

ARTG number: 152441

Type of regulatory action: Suspension from the ARTG under s.41GA(1)(b)

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.

Suspension start date: 9 Jun 2017

Suspension end date:

Thermo Fisher Scientific Australia Pty Ltd

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

ARTG number: 254033

Type of regulatory action: Suspended from the ARTG under s.41GA(1)(b)

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.

Suspension start date: 9 Jun 2017

Suspension end date:

Thermo Fisher Scientific Australia Pty Ltd

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

ARTG number: 199827

Type of regulatory action: Suspended from the ARTG under s.41GA(1)(b)

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.

Suspension start date: 2 Jun 2017

Suspension end date: 1 Jun 2018

Lovell Surgical Supplies International Pty Ltd

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

ARTG number: 262576

Type of regulatory action: Suspension from the ARTG under s.41GA(1)(b)

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

Further information:

A decision to extend the suspension period for an additional 6 months effective 02/12/2017 was made in accordance with section 41GC of the Therapeutic Goods Act 1989.

Following the submission of adequate evidence, the suspension has been revoked in accordance with section 41GD of the Act on 31 May 2018.

Suspension start date: 16 May 2017

Suspension end date: 16 Nov 2017

Philips Electronics Australia Ltd

Product name/ARTG reference: IntelliVue MX40

ARTG number: 99204

Type of regulatory action: Suspension from ARTG for a 6 month period under paragraph 41GA(1)(a)(i) of the Act

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.

Further information:

The suspension has been revoked in accordance with section 41 GD of the Act on 16 November 2017

Suspension start date: 21 Apr 2017

Suspension end date: 21 Apr 2018

Australian Blood Management Unit Trust

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

ARTG number: 278698

Type of regulatory action: Suspension from the ARTG under s.41GA(1)(b)

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.

The suspension has been revoked in accordance with section 41 GD of the Act on 20 April 2018.

2015

Suspension start date: 20 Nov 2015

Suspension end date: 4 Nov 2016

Device Technologies

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

ARTG number: 147758

Type of regulatory action: Suspension from the ARTG under s.41GA (1)(b)

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).

Suspension start date: 20 Nov 2015

Suspension end date: 4 Nov 2016

Device Technologies

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

ARTG number: 143152

Type of regulatory action: Suspension from the ARTG under s.41GA (1)(b)

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).

Suspension start date: 20 Nov 2015

Suspension end date: 4 Nov 2016

Device Technologies

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

ARTG number: 145286

Type of regulatory action: Suspension from the ARTG under s.41GA (1)(b)

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).

Suspension start date: 20 Nov 2015

Suspension end date: 4 Nov 2016

Device Technologies

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

ARTG number: 143151

Type of regulatory action: Suspension from the ARTG under s.41GA (1)(b)

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).

Suspension start date: 20 Nov 2015

Suspension end date: 4 Nov 2016

Device Technologies

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

ARTG number: 144436

Type of regulatory action: Suspension from the ARTG under s.41GA (1)(b)

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).

Suspension start date: 20 Nov 2015

Suspension end date: 4 Nov 2016

Device Technologies

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

ARTG number: 141293

Type of regulatory action: Suspension from the ARTG under s.41GA (1)(b)

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).

Suspension start date: 20 Nov 2015

Suspension end date: 4 Nov 2016

Device Technologies

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

ARTG number: 144278

Type of regulatory action: Suspension from the ARTG under s.41GA (1)(b)

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).

Suspension start date: 20 Nov 2015

Suspension end date: 4 Nov 2016

Device Technologies

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

ARTG number: 144276

Type of regulatory action: Suspension from the ARTG under s.41GA (1)(b)

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).

Suspension start date: 20 Nov 2015

Suspension end date: 4 Nov 2016

Device Technologies

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

ARTG number: 144275

Type of regulatory action: Suspension from the ARTG under s.41GA (1)(b)

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).

Suspension start date: 20 Nov 2015

Suspension end date: 4 Nov 2016

Device Technologies

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

ARTG number: 144274

Type of regulatory action: Suspension from the ARTG under s.41GA (1)(b)

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).

Suspension start date: 20 Nov 2015

Suspension end date: 4 Nov 2016

Device Technologies

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

ARTG number: 144273

Type of regulatory action: Suspension from the ARTG under s.41GA (1)(b)

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).

Suspension start date: 20 Nov 2015

Suspension end date: 4 Nov 2016

Device Technologies

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

ARTG number: 144272

Type of regulatory action: Suspension from the ARTG under s.41GA (1)(b)

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).

Suspension start date: 20 Nov 2015

Suspension end date: 4 Nov 2016

Device Technologies

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

ARTG number: 150019

Type of regulatory action: Suspension from the ARTG under s.41GA (1)(b)

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).

Suspension start date: 20 Nov 2015

Suspension end date: 4 Nov 2016

Device Technologies

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

ARTG number: 144271

Type of regulatory action: Suspension from the ARTG under s.41GA (1)(b)

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).

Suspension start date: 20 Nov 2015

Suspension end date: 4 Nov 2016

Device Technologies

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

ARTG number: 149275

Type of regulatory action: Suspension from the ARTG under s.41GA (1)(b)

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).

Suspension start date: 20 Nov 2015

Suspension end date: 4 Nov 2016

Device Technologies

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

ARTG number: 144270

Type of regulatory action: Suspension from the ARTG under s.41GA (1)(b)

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).

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