Siemens Linear Medical Accelerators equipped with COHERENCE Therapist R2.1 and Primeview 3 i R 2.1. Part numbers 5863506
FDA device recall Z-1768-2008 · posted 2008-09-04 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 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. C
- Date initiated
- 2007-09-19
- Date posted
- 2008-09-04
- Date terminated
- 2010-12-21
- Location
- Concord, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ONCOR EXPRESSION (K060226) | Siemens Medical Solutions USA, Inc. | 2006-03-15 |