FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: Radiation therapy system - Coherence Impression Therapist System equipped with a Coherence Therapist RTT2.1 or Primeview 3i R2.1 part number 7341410. Medical charged particle Radiation therapy system, part of the firm's beam limiting device/accessory. The product provides data processing, and the SYNGO standard medical imaging platform to provide comprehensive oncology workflow solutions for radiation therapy.
- Recall number
- Z-2096-2008
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Radiation therapy system - Coherence Impression Therapist System equipped with a Coherence Therapist RTT2.1 or Primeview 3i R2.1 part number 7341410. Medical charged particle Radiation therapy system, part of the firm's beam limiting device/accessory. The product provides data processing, and the SYNGO standard medical imaging platform to provide comprehensive oncology workflow solutions for radiation therapy.
- Status
- Terminated
- Initiated
- 2008-05-15
- Posted
- 2008-09-17
- Terminated
- 2010-12-20
- Reason
- Software - Under certain circumstances, the portal image may be overwritten, which may lead to incorrect dosage.
- Root cause
- Software design
- Action
- An Urgent Medical Device Correction - Customer Safety Advisory Notice letter (TH014/08/S) was released on May 15, 2008. A new software patch is under construction and is planned for release in June 2008. If you have any questions contact Roland Betz at (925) 246-8407.
- Quantity
- not on file
- Distribution
- Class II Recall - Product distribution information pending from firm.
- Lot, serial or model codes
- Medical Linear accelerators equipped with Coherence Therapist RTT2.1 or Primeview 3i R2.1 Software Numbers 8146503, 8149119, and 8163318. Applies only to those parts used with the following devices identified in the product descriptions.
- 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