FDA Medical Device Recalls (openFDA)
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
- Recall number
- Z-1768-2008
- 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
- Status
- Terminated
- Initiated
- 2007-09-19
- Posted
- 2008-09-04
- Terminated
- 2010-12-21
- 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.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K060226"]
- PMA numbers
- not on file
- Product code
- IYE
- Firm FEI
- 2937457
- Firm city
- Concord
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28