Coherence Dosimetrist, version 2.2. Intended use: Medical charged-particle radiation therapy system
FDA device recall Z-1834-2011 · posted 2011-03-28 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- 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.
- Action taken
- Affected consignees will be notified by the Customer Service Engineer to schedule a software update beginning November 2009.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MUJ
- Quantity affected
- 60 units
- Distribution
- Worldwide distribution: USA including: CA, KY, MI, NJ and TN; and countries of: Canada and Mexico.
- Date initiated
- 2009-11-06
- Date posted
- 2011-03-28
- Date terminated
- 2011-04-06
- Location
- Concord, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| COHERENCE DOSIMETRIST, MODEL 2.2 (K061097) | Siemens Medical Solutions USA, Inc. | 2006-06-07 |
| KONRAD, MODEL V.2.0 (K022307) | Mrc Systems GmbH | 2002-10-08 |