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U.S. Department of Health and Human Services

Class 2 Device Recall MOSAIQ Oncology Information System

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 Class 2 Device Recall MOSAIQ Oncology Information Systemsee related information
Date Initiated by FirmJanuary 11, 2011
Date PostedMarch 07, 2011
Recall Status1 Terminated 3 on April 19, 2012
Recall NumberZ-1572-2011
Recall Event ID 57732
Product Classification Linear Medical Accelerator - Product Code IYE
ProductMOSAIQ Oncology Information System Intended Use : Electronic Patient Records Management
Code Information Part # 10568605
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		The potential for injury to a patient should the treatment data be incorrectly uploaded to patient records.
FDA Determined
Cause 2		Software design (manufacturing process)
ActionSent an Urgent Medical Device Correction Safety Advisory Notice to customers on 1/11/11. Letters will be delivered by Siemens Customer Service Group or sent by certified mail. Letter identified the affected product and stated there is a potential risk due to a problem identified by the manufacturer. Customers are asked to refer to the attached Safety Notice from Elekta IMPAC Software. A Siemens Service Engineer will contact customers site to arrange for a patient matching criteria audit to determine if you have a problem. Customers should include the Safety Advisory Notice including the Safety Notice from Elekta IMPAC Software in their product related documentation until further notice. If customers have any questions, they should contact their responsible SIEMENS Service Engineer or Application Specialist.
Quantity in Commerce10 units
DistributionInternational Only Distribution -- Germany and Japan
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.
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