FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: Coherence Impression Therapist System equipped with a Coherence Therapist R2.0 or R2.1, and PRIMEVIEW 3iR2.0 or R2.1, part number 7341410 Medical charged-particle radiation therapy system.
- Recall number
- Z-0091-2009
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Coherence Impression Therapist System equipped with a Coherence Therapist R2.0 or R2.1, and PRIMEVIEW 3iR2.0 or R2.1, part number 7341410 Medical charged-particle radiation therapy system.
- Status
- Terminated
- Initiated
- 2007-11-06
- Posted
- 2008-10-16
- Terminated
- 2010-12-18
- Reason
- Flat panel positioning calibration could be off by as much as 4 mm without the machine discovering detail.
- Root cause
- Software design
- Action
- Service calibration inspection/correction Update instructions TH038/07/S was issued on 11/06/2007 to all customers. The instructions identified the affected products, stated the reason for the update, and listed the steps to update the software. Customer notification was also issued. Software patch planned for release in June 2008.
- Quantity
- 33 units
- Distribution
- Worldwide Distribution
- Lot, serial or model codes
- Serial numbers associated with RTT2.0 and RTT2.1
- 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
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
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