GammaMed software program, version 5.07, vers. 5.08, vers.-usa, vers.-tst and vers.-row , part number GM11005400, for th
FDA device recall Z-1398-06 · posted 2006-08-10 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems
- Reason for recall
- Software control program for a medical device used in radiation treatment may cause practitioners to incorrectly administer the treatment plan to cancer patients. There is a hazard when entering the treatment plans manually that the user neglects to change the default step size and/or the origin or accidentally enters incorrect parameters.
- Action taken
- The recalling firm notified healthcare practitioners using the medical device by letter on 4/17/06 and continuing through 5/1/06. The notification was flagged as a 'Medical Device Recall' and instructed users to adjust system parameters in the autoexec.bat file. The notification further recommended using the identified treatment plans and that manual input should be used for QA purposes only.
- Root cause
- Other
- Status
- Terminated
- Product code
- JAQ
- Quantity affected
- 22 units
- Distribution
- Nationwide.
- Date initiated
- 2006-05-01
- Date posted
- 2006-08-10
- Date terminated
- 2006-12-05
- Location
- Charlottesville, VA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GAMMAMED 12I (K891131) | Mick Radio-Nuclear Instruments, Inc. | 1989-08-07 |