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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 System see related information
Date Initiated by Firm January 11, 2011
Date Posted March 07, 2011
Recall Status1 Terminated 3 on April 19, 2012
Recall Number Z-1572-2011
Recall Event ID 57732
Product Classification Linear Medical Accelerator - Product Code IYE
Product MOSAIQ Oncology Information System

Intended Use : Electronic Patient Records Management
Code Information Part # 10568605
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		 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)
Action Sent 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 Commerce 10 units
Distribution International Only Distribution -- Germany and Japan
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.
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