Varian Medical Systems On-Board Imager, Versions 1.0.15 and 1.2.05 Imaging Accessory to Medical Linear Accelerator. The
FDA device recall Z-1442-2008 · posted 2008-08-15 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems Oncology Systems
- Reason for recall
- If used with a third party radiation therapy treatment planning software system, mistreatment may occur because of a misalignment.
- Action taken
- The firm has upgraded all user sites through normal course of service and installation activities. Notification letters were distributed starting January 03, 2008.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 291 units
- Distribution
- Worldwide Distribution -- USA including states of GA, MI, NY, MN, TX, TN, CA, MD, KS, AL, KY, CT, WI, LA, NC, NJ, PA, IL, RI, FL, NE, AK, VA, WV, NV, MO, TN, OR, IN, MA, CT, AL, AZ, NH, ID, OH, SC, CO
- Date initiated
- 2008-01-03
- Date posted
- 2008-08-15
- Date terminated
- 2010-11-27
- 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 |
|---|---|---|
| ON-BOARD IMAGER DEVICE (K042720) | Varian Medical Systems | 2004-10-29 |
| MODIFICATION TO: ON-BOARD IMAGER DEVICE (K041519) | Varian Medical Systems, Inc. | 2004-08-04 |
| ON-BOARD IMAGER DEVICE (K040192) | Varian Medical Systems, Inc. | 2004-02-27 |