GammaWin software, part number GM11019110, versions up to and including 1.62, for the GammaMedplus radionuclide applicat
FDA device recall Z-1268-06 · posted 2006-07-27 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems
- Reason for recall
- 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.
- Action taken
- The recalling firm notified end users by letter on 05/01/06 and advised users of possible communication error between afterloader devices and software. The notification also advised that the control program for the devices has the potential to lead to a misadministration of treatment in cases where data is manually entered by the user. The firm additionally advised that user may continue to use the afterloader devices if following the listed cautionary statements. A software upgrade is planned to be implemented at the user site''s next regularly scheduled radiation source exchange. A response form is enclosed with the notification and users are requested to return the customer receipt verification via fax.
- Root cause
- Other
- Status
- Terminated
- Product code
- JAQ
- Quantity affected
- 254 total units
- Distribution
- Nationwide and worldwide.
- Date initiated
- 2006-05-01
- Date posted
- 2006-07-27
- Date terminated
- 2007-05-18
- Location
- Charlottesville, VA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GAMMAMED PLUS HIGH DOSE RATE REMOTE AFTERLOADING SYSTEM (K983436) | Gammamed USA | 1998-10-29 |