Siemens Medical Solutions USA, Inc Coherence Dosimetrist, version 2.2. Intended use: Medical charged-particle radiation therapy system Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Coherence Dosimetrist, version 2.2. Intended use: Medical charged-particle radiation therapy system
Brand
Siemens Medical Solutions USA, Inc
Lot Codes / Batch Numbers
Version 2.2, Part No. 081239953 Version 2.2.23 SPI Patch, Part No. 08164365
Products Sold
Version 2.2, Part No. 081239953 Version 2.2.23 SPI Patch, Part No. 08164365
Siemens Medical Solutions USA, Inc is recalling Coherence Dosimetrist, version 2.2. Intended use: Medical charged-particle radiation therapy system due to 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 organ. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Affected consignees will be notified by the Customer Service Engineer to schedule a software update beginning November 2009.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, KY, MI, NJ, TN
Page updated: Jan 10, 2026