VARiS 1.4G and Vision/SomaVision Radiation Therapy Systems; VARiS versions 6.1.33 and 6.2.19 in conjunction with Eclipse
FDA device recall Z-0633-03 · posted 2003-03-12 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems Inc
- Reason for recall
- The product has a software problem. This could result in a treatment without a motorized wedge where one had been planned.
- Action taken
- On 1/16/03 and 2/4/03 (2nd notification) the firm initiated the recall and their notification was via letters to inform its consignees about the new VARiS version 6.2.27 release.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 12 units
- Distribution
- Product was released for distribution to 7 hospitals in the US. Distribution was limited to the following States: CA, MA, NC, SC, PA, and LA. 1 (one) Canadian distribution includes Fraser Valley Cance
- Date initiated
- 2003-01-31
- Date posted
- 2003-03-12
- Date terminated
- 2003-09-17
- Location
- Palo Alto, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VARIS 1.4G (K001643) | Varian Medical Systems, Inc. | 2000-06-23 |