GammaMed 12i radionuclide applicator systems, distributed by Varian Medical Systems, Palo Alto, CA
FDA device recall Z-0486-2007 · posted 2007-01-11 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems
- Reason for recall
- Medical device for patient treatment does not meet electrical safety standards.
- Action taken
- The recalling firm notified end users by e-mail and letter on 09/11/06 and advised that some devices did not comply with electrical safety standards. The firm stated that they plan to make modifications to improve electrical safety performance but users may continue to use the device to treat patients. The notification included a response form for users to fax back verification of receipt.
- Root cause
- Other
- Status
- Terminated
- Product code
- JAQ
- Quantity affected
- 31 total units
- Distribution
- Worldwide distribution, including NC, GA, IN, IL and AZ in USA, Germany, South Korea, Switzerland, Belgium, and Brazil.
- Date initiated
- 2006-09-11
- Date posted
- 2007-01-11
- Date terminated
- 2007-05-18
- Location
- Charlottesville, VA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GAMMAMED 12IT HIGH DOSE RATE REMOTE AFTERLOADER (K912555) | Rts Technology, Inc. | 1991-08-02 |
| GAMMAMED 12I (K891131) | Mick Radio-Nuclear Instruments, Inc. | 1989-08-07 |