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
Hazard
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.
What You Should Do
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.
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Products
- Brand
- Siemens Medical Solutions USA, Inc
- UPC
- All Siemens Linear Medical Accelerators equipped with COHERENCE Therapist R2.1 and PrimeView 3i R2.1. System, Part Numbers listed below: COHERENCE AG Therapist, 5863506 COHERENCE Therapist System, 7339125 COHERENCE Impression Therapist, 7341410 Primeview 3i, 7341428 AG Therapist 3rd Party V&R, 7345411 Impression Therapist 3rd Party V&R, 7345429 syngo based WS for 3rd Party V&R, 7345437 Coherence Therapist 2.0, 8139839 Primveview 3i 2.0, 8139847 Coherence Therapist 2.1, 8147667 and Primeview 3i 2.1, 8147675
Units Affected
143 units, 113 active