Z-1768-2008

Siemens Linear Medical Accelerators equipped with COHERENCE Therapist R2.1 and Primeview 3 i R 2.1. Part...

Name: Z-1768-2008 Siemens Linear Medical Accelerators equipped with COHERENCE Therapist R2.1 and Primeview 3 i R 2.1. Part...
Creator: Siemens Medical Solutions USA, Inc
Published: 2007-09-19
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2007-09-19 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of Siemens Linear Medical Accelerators equipped with COHERENCE Therapist R2.1 and Primeview 3 i R 2.1. Part numbers 5863506, 7339125, 7341410, 7341428, 7345411... on 2007-09-19. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1768-2008
Status: Terminated
Initiated: 2007-09-19
Posted: 2008-09-04
Terminated: 2010-12-21
Recalling firm: Siemens Medical Solutions USA, Inc.
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
Product code: IYE Accelerator, Linear, Medical
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.
Root cause tag: software
FDA 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 in commerce: 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.
Product codes and lots: 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

Product code IYE

K060226Class IIOncor ExpressionSiemens Medical Solutions USA, Inc. / cleared 2006-03-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)