FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: Coherence Dosimetrist, version 2.2. Intended use: Medical charged-particle radiation therapy system
- Recall number
- Z-1834-2011
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Coherence Dosimetrist, version 2.2. Intended use: Medical charged-particle radiation therapy system
- Status
- Terminated
- Initiated
- 2009-11-06
- Posted
- 2011-03-28
- Terminated
- 2011-04-06
- Reason
- A problem in the software has the potential to be associated with the dose; when a template is created the user has the possibility to predefine organs. For the Target the user defines the max. dose and the min dose, for the OAR (Organs at Risk) the user only defines the max. dose. The firms engineering team determined that the software defect was repeatable.
- Root cause
- Software design
- Action
- Affected consignees will be notified by the Customer Service Engineer to schedule a software update beginning November 2009.
- Quantity
- 60 units
- Distribution
- Worldwide distribution: USA including: CA, KY, MI, NJ and TN; and countries of: Canada and Mexico.
- Lot, serial or model codes
- Version 2.2, Part No. 081239953 Version 2.2.23 SPI Patch, Part No. 08164365
- 510(k) numbers
- ["K022307","K061097"]
- PMA numbers
- not on file
- Product code
- MUJ
- 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