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U.S. Department of Health and Human Services

Class 2 Device Recall Coherence Dosimetrist, v 2.2

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 Class 2 Device Recall Coherence Dosimetrist, v 2.2see related information
Date Initiated by FirmNovember 06, 2009
Date PostedMarch 28, 2011
Recall Status1 Terminated 3 on April 06, 2011
Recall NumberZ-1834-2011
Recall Event ID 54706
510(K)NumberK022307 K061097 
Product Classification System, planning, radiation therapy treatment - Product Code MUJ
ProductCoherence Dosimetrist, version 2.2. Intended use: Medical charged-particle radiation therapy system
Code Information Version 2.2, Part No. 081239953 Version 2.2.23 SPI Patch, Part No. 08164365
FEI Number 2937457
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
4040 Nelson Ave
Concord CA 94520-1200
For Additional Information ContactChristine Dunbar
925-246-8407
Manufacturer 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.
FDA Determined
Cause 2		Software design
ActionAffected consignees will be notified by the Customer Service Engineer to schedule a software update beginning November 2009.
Quantity in Commerce60 units
DistributionWorldwide distribution: USA including: CA, KY, MI, NJ and TN; and countries of: Canada and Mexico.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = MUJ
510(K)s with Product Code = MUJ
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