Recall Z-0089-2009 ยท IYE Accelerator, Linear, Medical
Siemens Medical Solutions USA, Inc
Coherence AG Therapist Part number 5863506, equipped with a Coherence Therapist R2.0 or R2.1, and PRIMEVIEW 3iR2.0 or R2.1 Medical charged-particle radiation therapy system.
| Date | Oct 16, 2008 (initiated Nov 6, 2007) |
| Status | Terminated |
| Reason | Flat panel positioning calibration could be off by as much as 4 mm without the machine discovering detail. |
| Root cause | Software design |
| Action | Service calibration inspection/correction Update instructions TH038/07/S was issued on 11/06/2007 to all customers. The instructions identified the affected products, stated the reason for the update, and listed the steps to update the software. Customer notification was also issued. Software patch planned for release in June 2008. |
| Quantity | 14 units. |
| Distribution | Worldwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060226 | ONCOR EXPRESSION Siemens Medical Solutions USA, Inc., Mar 15, 2006 |