Recall Z-0949-2009 ยท IYE Accelerator, Linear, Medical
Siemens Medical Solutions USA, Inc
Artiste MV Digital Linear Accelerator System Equipped with 160 MCL Accessory Holder, Manufactured by Siemens Medical Solutions, Oncology Care System, Concord, CA Medical charged-particle radiation therapy system.
| Date | Jan 30, 2009 (initiated Dec 20, 2008) |
| Status | Terminated |
| Reason | The range of tolerance is to high for the accessory holder, therefore, Wedges and other accessories do not latch to the locking mechanism correctly. |
| Root cause | Device Design |
| Action | On 12/20/08, the firm issued letters via certified mail to direct consignees, informing them of the affected product and providing instructions on the recall. Contact Siemens Medical Solutions USA, Inc. at 1-925-246-8407 for additional information. |
| Quantity | 43 units |
| Distribution | Nationwide and Worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072485 | ARTISTE MV SA Siemens Medical Solutions USA, Inc., Dec 27, 2007 |