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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 Recall
Coherence Dosimetrist, v 2.2
see related information
Date Posted March 28, 2011
Recall Status1 Terminated on April 06, 2011
Recall Number Z-1834-2011
Recall Event ID 54706
Premarket Notification
510(K) Numbers
K022307  K061097 
Product Classification System,Planning,Radiation Therapy Treatment - Product Code MUJ
Product Coherence 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
Recalling Firm/
Manufacturer
Siemens Medical Solutions USA, Inc
4040 Nelson Ave
Concord, California 94520-1200
For Additional Information Contact Christine 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
DESIGN: 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MUJ and Original Applicant = MRC SYSTEMS GMBH
510(K)s with Product Code = MUJ and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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