Varian brand Clinac, Accelerator, Linear, Medical charged-particle radiation therapy system: Model: High Energy Clinacs
FDA device recall Z-0544-2008 · posted 2008-02-14 · Terminated
Recall details
- Recalling firm
- Varian Medical Systems Inc
- Reason for recall
- Treatment Error: The collimator drive chain may break or slip off of its drive track, allowing the collimator to rotate freely without motor control; if undetected resulting in a treatment with the wrong collimator angle.
- Action taken
- On 9/10/07, the firm issued an Urgent Medical Device Correction letter to all its direct consignees, informing them of the device defect and providing instructions on the recall. Short term user instructions were provided and the firm will schedule follow-up visits to make the needed permanent device corrections at each device site.
- Root cause
- Labeling design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 418 (total for Recalls Z-0544-0545-2008)
- Distribution
- Worldwide- Canada, Mexico, and the USA
- Date initiated
- 2007-09-10
- Date posted
- 2008-02-14
- 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 |
|---|---|---|
| TRILOGY RADIOTHERAPY DELIVERY SYSTEM AND TRILOGY TX DELIVERY SYSTEM (K070094) | Varian Medical Systems, Inc. | 2007-02-09 |