Mevatron KDS-2 Medical Linear Accelerator, Material Number: 9822693, with control console software versions 6.5/7.2, 8.0
FDA device recall Z-1402-2008 · posted 2008-04-02 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- Linear accelerator gantry may rotate in an unexpected direction and may cause patient injury on impact.
- Action taken
- This is a mandatory software upgrade for consignees. The firm's representatives have contacted consignees via Urgent Device Notification letters dated February 14, 2008, notifying them of the new update and making arrangements to install it.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 2 units
- Distribution
- Worldwide-USA including states of AL, AK, AZ, AR, CA, CO, DE, DC, FL, GA, IL, IN, KS, KY, LA, MD, ME, MI, MN, MS, MO, MN, NE, NV, NH, NJ, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, VT, VA, WA, WV
- Date initiated
- 2008-01-11
- Date posted
- 2008-04-02
- Date terminated
- 2011-05-06
- Location
- Concord, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MEVATRON, M 2 CLASS (K882729) | Siemens Medical Laboratories, Inc. | 1988-09-19 |