GammaMed Flexible Applicator Probe, Part GM11002560 - 3.2 mm diameter braced PVDF. Varian Medical Systems, Palo Alto, CA
FDA device recall Z-0295-2012 · posted 2011-11-30 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems, Inc.
- Reason for recall
- GammaMed Flexible Applicator Probes may not have been heat annealed during manufacturing to prevent shrinkage after autoclave.
- Action taken
- Varian Medical Systems, Inc. sent a Customer Technical Bulletin CTB-GM-603A on August 5, 2008 to all affected customers. The letter included description of device and problem. The bulletin also advised that if they find that the applicator and source guide tube combination is not within the indicated range on the length gauge, to call VBT technical support using the contact information on page 5 of the bulletin to obtain a replacement applicator probe. Customers are to complete and return the attached verification card. If support is needed the letter provides customer support contact information.
- Root cause
- Process control
- Status
- Terminated
- Product code
- JAQ
- Quantity affected
- 653 parts
- Distribution
- Worldwide Distribution -- USA (nationwide): Arkansas,California, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kentucky, Maine, Maryland, Massachusetts, Minnesota, Montana, Michigan, Missou
- Date initiated
- 2008-08-05
- Date posted
- 2011-11-30
- Date terminated
- 2011-12-07
- Location
- Charlottesville, VA
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|---|---|---|
| GAMMAMED PLUS HIGH DOSE RATE REMOTE AFTERLOADING SYSTEM (K983436) | Gammamed USA | 1998-10-29 |