Recall Z-0380-2008 ยท IYE Accelerator, Linear, Medical
Siemens Medical Solutions USA, Inc
Siemens, Mevatron M2/PRIMUS Plus, Part No.: 45 04 200, High EnergyMedical Charge particle radiation therapy system with pre-R2.0 Optivue Flat Panel Positioners, Siemens Medical, Concord, CA 94520
| Date | Dec 1, 2007 (initiated Mar 23, 2007) |
| Status | Terminated |
| Reason | Product's collision detection system may not be sensitive enough to trigger a stop action without a significant amount of force. |
| Root cause | Device Design |
| Action | 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. |
| Quantity | 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, Australia, Austria, Belgium, Canada, Denmark, El Salvador, France, Germany, Hungary, India, Ireland, It |
| FDA record | Open on fda.gov |