Recall Z-1768-2008 ยท IYE Accelerator, Linear, Medical
Siemens Medical Solutions USA, Inc
Siemens Linear Medical Accelerators equipped with COHERENCE Therapist R2.1 and Primeview 3 i R 2.1. Part numbers 5863506, 7339125, 7341410, 7341428, 7345411, 7345429, 7345437, 8139839, 8139847, 8147667, and 8147675
| Date | Sep 4, 2008 (initiated Sep 19, 2007) |
| Status | Terminated |
| Reason | Images may potentially shift, causing an incorrect alignment of the patient, which may result in a dose to the wrong location. It was discovered through the complaint handling process that a potential image shift issue can occur after using the interactive shift tool and filtering tool due to incorrect consideration of the flat panel alignment. |
| Root cause | Software design |
| Action | A Customer Safety Advisory Notice was issued on September 19, 2007--All affected consignees were notified certified mail (includes update instruction TH029/07/S). Customers were request to maintain a copy of the safety advisory notice with the COHERENCE Therapist R2.1/Primeview 3i manuals. A copy of the firm's corrections & removal report will be forwarded to Quality Management of Siemens Regional units responsible for reporting to local country authorities and a copy of the report is also forwarded to the firm's distributor. |
| Quantity | 143 units, 113 active |
| Distribution | Class II Recall - Worldwide Distribution --- including USA, Algeria, Argentina, Australia, Canada, Colombia, Croatia, Egypt, France, Germany, Hungary, India, Ireland, Italy, Japan, New Zealand, P.R. China, Poland, Russian Fed., Saudi Arabia, South Africa, Spain, Turkey. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060226 | ONCOR EXPRESSION Siemens Medical Solutions USA, Inc., Mar 15, 2006 |