Date Initiated by Firm |
November 06, 2009 |
Date Posted |
March 28, 2011 |
Recall Status1 |
Terminated 3 on April 06, 2011 |
Recall Number |
Z-1834-2011 |
Recall Event ID |
54706 |
510(K)Number |
K061097 K022307
|
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 CA 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 |
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 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) 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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