Gammamed Plus High Dose Rate Remote Afterloading System

• Terminated Z-0607-2013 FDA Class II ·initiated 28 Sep 2012

The guide tube which is part of the Segmented Cervix Applicator Set is difficult to disconnect from cervical sleeve.

6 recalls, same reason

• Terminated Z-2997-2011 FDA Unclassified (pre-2012) ·initiated 13 Jul 2011
• Terminated Z-2995-2011 FDA Unclassified (pre-2012) ·initiated 13 Jul 2011
• Terminated Z-2998-2011 FDA Unclassified (pre-2012) ·initiated 13 Jul 2011
• Terminated Z-2999-2011 FDA Unclassified (pre-2012) ·initiated 13 Jul 2011
• Terminated Z-3000-2011 FDA Unclassified (pre-2012) ·initiated 13 Jul 2011
• Terminated Z-2996-2011 FDA Unclassified (pre-2012) ·initiated 13 Jul 2011

Potential of weld failure of the Titanium intrauterine probe at the cervical stopper.

• Terminated Z-3013-2011 FDA Unclassified (pre-2012) ·initiated 13 Jul 2011

Certain GammaMed Flexible applicator probes may not have been heat annealed during manufacturing to prevent shrinkage after autoclave.

3 recalls, same reason

• Terminated Z-2993-2011 FDA Unclassified (pre-2012) ·initiated 13 Jul 2011
• Terminated Z-2991-2011 FDA Unclassified (pre-2012) ·initiated 13 Jul 2011
• Terminated Z-2992-2011 FDA Unclassified (pre-2012) ·initiated 13 Jul 2011

Needle tip may separate from the needle shaft such that the tip may detach in the patient upon withdrawal.

3 recalls, same reason

• Terminated Z-0327-2012 FDA Unclassified (pre-2012) ·initiated 30 Sep 2008
• Terminated Z-0326-2012 FDA Unclassified (pre-2012) ·initiated 30 Sep 2008
• Terminated Z-0328-2012 FDA Unclassified (pre-2012) ·initiated 30 Sep 2008

Plastic needle tip could possibly crack or separate.

• Terminated Z-0295-2012 FDA Unclassified (pre-2012) ·initiated 5 Aug 2008

GammaMed Flexible Applicator Probes may not have been heat annealed during manufacturing to prevent shrinkage after autoclave.

• Terminated Z-1268-06 FDA Unclassified (pre-2012) ·initiated 1 May 2006

Medical device software for brachytherapy may cause erroneous data to be recorded and affect patient radiation treatments. Erroneous data may be listed on the treatment history report, and the default step size may lead to a misadministration if treatment data is entered manually.

• Terminated Z-0921-05 FDA Unclassified (pre-2012) ·initiated 14 Apr 2005

A defective treatment applicator in a cancer therapy medical device may become separated potentially causing patient injury.