Clinac with Version 7.x Software, manufactured by Varian Medical Systems, Palo Alto, CA. Part of the Trilogy Radiotherap
FDA device recall Z-1729-2009 · posted 2009-08-27 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems Oncology Systems
- Reason for recall
- Unexpected Movement: if the stereotactic motion disable function is turned on, the couch can be moved via float mode unexpectedly.
- Action taken
- Varian Medical Systems issued an "Urgent Medical Device Correction" dated May 29, 2009 distributed to all affected users, as well as Varian Sales, Marketing and Service organizations, informing them of the issue. Consignees were informed that a Varian Service representative will be in contact to schedule the proper correction. For further questions, contact your local Varian Customer Support District Manager.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 1,933 units
- Distribution
- Worldwide Distribution.
- Date initiated
- 2009-05-29
- Date posted
- 2009-08-27
- Date terminated
- 2011-05-18
- 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 |
|---|---|---|
| VARIAN C-SERIES CLINACS CLINAC 600C,2100C,2500C (K904364) | Varian Assoc., Inc. | 1991-02-27 |