Varian Radiotherapy delivery system (C-Series Clinac, Trilogy and Novalis Tx), model numbers H14, H17, H18, H23, H26, H2
FDA device recall Z-1249-2011 · posted 2011-02-15 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems Oncology Systems
- Reason for recall
- Position errors may result in misdelivery of radiation.
- Action taken
- Varian sent Urgent Medical Device Correction letters on June 23, 2010 by Federal Express to all 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.*** Field Safety notification including customer distribution lists, was e-mailed to Varian international Customer Support Managers. Managers will translate to local language if necessary, notify sites by appropriate methods.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 5741 units
- Distribution
- Worldwide distribution.
- Date initiated
- 2010-06-23
- Date posted
- 2011-02-15
- Date terminated
- 2011-05-03
- 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 RADIOTHERAPY DELIVERY SYSTEM AND TRILOGY TX DELIVERY SYSTEM (K070094) | Varian Medical Systems, Inc. | 2007-02-09 |
| VARIAN C-SERIES CLINACS (CLINAC 2300C/D) (K913119) | Varian Assoc., Inc. | 1991-11-07 |
| VARIAN C-SERIES CLINACS CLINAC 600C,2100C,2500C (K904364) | Varian Assoc., Inc. | 1991-02-27 |