Alerts

Owners and people responsible for HeartSine PAD 300/PAD 300P public access defibrillators are advised that Aero Healthcare, in consultation with the TGA, undertook a recall for product correction of some of these devices in November 2012 to correct certain battery and software problems that may affect the ability of the device to work in the event it is needed.

Ausmedic Australia is undertaking a recall for product correction for certain models of Viper and Viper Plus powered wheelchairs

Consumers and health professionals are advised that Hill-Rom, in consultation with the TGA, is undertaking a recall for product correction for the Liko Standard SlingBar 450.

Consumers and health professionals are advised that Mobility Plus, in consultation with the TGA, is undertaking a recall for product correction of Crocodile size 3 walkers.

A hazard alert has been issued to cardiologists and surgeons regarding some models of Cognis Cardiac Resynchronisation Therapy Defibrillators (CRT-Ds) and Teligen Implantable Cardioverter Defibrillators (ICDs).

Stryker Australia, in consultation with the TGA, has issued a hazard alert to surgeons regarding OtisMed ShapeMatch Cutting Guides.

Consumers and health professionals are advised that LMT Surgical is issuing a hazard alert for all sizes and lots of its PyroTitan humeral resurfacing arthroplasty device.

Boston Scientific has initiated a recall for product correction for multiple lots of its Promus Element Plus Monorail everolimus-eluting coronary stent system.

Consumers and health professionals are advised that Novo Nordisk Pharmaceuticals, in consultation with the TGA, has initiated a recall for product correction of certain lots of its NordiPen medical device.

Consumers and health professionals are advised that Stryker Australia, in consultation with the TGA, has issued a hazard alert to surgeons regarding its Oasys Midline Occipital Plate.

Consumers and health professionals are advised that Medtronic Australasia, in consultation with the TGA, has initiated a recall for product correction for its Medtronic SynchroMed II and SynchroMed EL implantable infusion pumps.

Health professionals and consumers are advised that Medtronic Australasia is issuing a hazard alert for its Consulta Cardiac Resynchronization Therapy Pacemaker (CRT-P).

Health professionals and consumers are advised that GE Healthcare, in consultation with the TGA, has initiated a recall for product correction for a number of its nuclear medicine imaging systems.

B. Braun Australia is withdrawing the cementless version of the Columbus Knee System from the Australian Register of Therapeutic Goods (ARTG). They have also issued a related hazard alert to surgeons.

Synthes Australia, in consultation with the TGA, is recalling unused stock of its 3.7 mm and 5.0 mm Dynamic Locking Screws.