Recall Z-1834-2011 ยท MUJ System, Planning, Radiation Therapy Treatment
Siemens Medical Solutions USA, Inc
Coherence Dosimetrist, version 2.2. Intended use: Medical charged-particle radiation therapy system
| Date | Mar 28, 2011 (initiated Nov 6, 2009) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |