Recall Z-0782-2012 ยท IYE Accelerator, Linear, Medical
Siemens Medical Solutions USA, Inc
PRIMUS HI; Siemens Healthcare Concord, CA 94520 Product Usage: PRIMUS and MEVATRON Linear Accelerators are intended to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.
| Date | Jan 17, 2012 (initiated Dec 1, 2011) |
| Status | Terminated |
| Reason | Bolts holding the trim weight may break causing the plates of the counterweight to become loose and fall into the cover. |
| Root cause | Nonconforming Material/Component |
| Action | Siemens sent a Customer Information Letter on December 1, 2011 to all affected customers. The letter idenfied what is the issue, when does the issue occur and what Siemens will do to address the issue. The letter recommend that the Customer Information letter be included in the Linear Accelerator System Owner manual chapter Safety Advisory Letters. |
| Quantity | 327 Active Devices - all models |
| Distribution | Worldwide Distribution - USA (nationwide) |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K993425 | PRIMUS Siemens Medical Solutions USA, Inc., Nov 26, 1999 |