Siemens, Mevatron M2/PRIMUS Plus, Part No.: 45 04 200, High EnergyMedical Charge particle radiation therapy system with
FDA device recall Z-0380-2008 · posted 2007-12-01 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- Product's collision detection system may not be sensitive enough to trigger a stop action without a significant amount of force.
- Action taken
- The firm has issued a Customer Safety Advisory Notice dated 12/6/2006, to all sites that have the pre-R2.0 OPTIVUE Flat Panel Positioners installed. Users will have a new microswitch-based collision detection system, installed free of charge.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 64 units
- Distribution
- Worldwide Distribution- USA including MA, ME, NJ, NY, PA, MD, WV, NC, SC, GA, FL, AL, TN, KY, OH, IN, MI, IA, WI, SD, ND, MT, IL, NE, LA, OK, TX, WY, NV, CA, AK AND AR, and countries of Serbia, Austra
- Date initiated
- 2007-03-23
- Date posted
- 2007-12-01
- Date terminated
- 2011-02-11
- 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 |
|---|---|---|
| ONCOR AVANT-GARDE WITH COHERENCE WORKSPACES (K031764) | Siemens Medical Solutions USA, Inc. | 2003-09-05 |
| PRIMUS (K993425) | Siemens Medical Solutions USA, Inc. | 1999-11-26 |