Desktop Pro R6.0 & R6.1, Linear Medical Accelerator.
FDA device recall Z-0421-2007 · posted 2007-02-07 · Terminated
Recall details
- Recalling firm
- Elekta, Inc.
- Reason for recall
- Unexpected Diaphragm movement when manual field size modifications are not saved.
- Action taken
- Consignees were notified by letter on/about 11/23/2006
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 37 units
- Distribution
- Worldwide distribution ---- including USA states of AZ, AL, CA, CO, FL, GA, IA, MI, NV, OH, OK, PA, WA, WV and Country of Canada .
- Date initiated
- 2006-11-23
- Date posted
- 2007-02-07
- Date terminated
- 2008-05-14
- Location
- Norcross, GA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| RT DESKTOP (K982713) | Elekta Oncology Systems, Ltd. | 1998-11-02 |