On-Board Imager (OBI) 1.3, 1.4, 1.5; and Trilogy Mx, TrueBeam 1.0, Offline Review 1.0 - 2.0; Product is manufactured and
FDA device recall Z-3101-2011 · posted 2011-08-31 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems, Inc. Oncology Systems
- Reason for recall
- Varian has identified a software anomaly in the 3D Match environment, regarding a slight mismatch between CT image and Structures in On-Board Imager w/s.
- Action taken
- Varian Medical Systems sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated June 21, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. ***12-20-12, AMENDED INFO ***: An additional letter was sent to consignees on 11/5/12 that Varian identified as also being affected by the recall.*** The letter recommends several user actions. The firm is developing a correction for the issue and will contact customers when the correction is available. Questions regarding this notice may be addressed by contacting the Varian Oncology Help Desk at 1-888-827-4265.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 2268
- Distribution
- Worldwide Distribution
- Date initiated
- 2011-06-21
- Date posted
- 2011-08-31
- Date terminated
- 2012-03-15
- 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 |
|---|---|---|
| TRILOGY MX (K092871) | Varian Medical Systems, Inc. | 2009-11-30 |
| ON-BOARD IMAGER DEVICE (K042720) | Varian Medical Systems | 2004-10-29 |