Z-1834-2011

Coherence Dosimetrist, version 2.2

Name: Z-1834-2011 Coherence Dosimetrist, version 2.2
Creator: Siemens Medical Solutions USA, Inc
Published: 2009-11-06
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2009-11-06 / Terminated / root cause: software

FDA source

Siemens Medical Solutions USA, Inc began a recall of Coherence Dosimetrist, version 2.2. Intended use: Medical charged-particle radiation therapy system on 2009-11-06. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1834-2011
Status: Terminated
Initiated: 2009-11-06
Posted: 2011-03-28
Terminated: 2011-04-06
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Coherence Dosimetrist, version 2.2. Intended use: Medical charged-particle radiation therapy system
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: 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 tag: software
FDA root cause: Software design
Action: Affected consignees will be notified by the Customer Service Engineer to schedule a software update beginning November 2009.
Quantity in commerce: 60 units
Distribution: Worldwide distribution: USA including: CA, KY, MI, NJ and TN; and countries of: Canada and Mexico.
Product codes and lots: Version 2.2, Part No. 081239953 Version 2.2.23 SPI Patch, Part No. 08164365

Product code MUJ

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)