—#70071

Product

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

FDA product code: IYE — Accelerator, Linear, Medical
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K060226
Affected lot / code info: 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

Why it was recalled

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 (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 4040 Nelson Ave, Concord, California 94520-1200

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2007-09-19
Posted by FDA: 2008-09-04
Terminated: 2010-12-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #70071. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.