—#89038

Product

Coherence Dosimetrist, version 2.2. Intended use: Medical charged-particle radiation therapy system

FDA product code: MUJ — System, Planning, Radiation Therapy Treatment
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K022307, K061097
Affected lot / code info: Version 2.2, Part No. 081239953 Version 2.2.23 SPI Patch, Part No. 08164365

Why it was recalled

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 (FDA determination)

Software design

Action the firm took

Affected consignees will be notified by the Customer Service Engineer to schedule a software update beginning November 2009.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 4040 Nelson Ave, Concord, California 94520-1200

Distribution

Distribution pattern: Worldwide distribution: USA including: CA, KY, MI, NJ and TN; and countries of: Canada and Mexico.

Timeline

Recall initiated: 2009-11-06
Posted by FDA: 2011-03-28
Terminated: 2011-04-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #89038. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.