MOSAIQ Oncology Information System Intended Use : Electronic Patient Records Management
This recall has been terminated (originally issued March 7, 2011).
- Recall Initiated
- January 11, 2011
- Posted
- March 7, 2011
- Terminated
- April 19, 2012
- Recall Number
- Z-1572-2011
- Quantity
- 10 units
- Firm Location
- Concord, CA
- Official Source
- View on FDA website ↗
Reason for Recall
The potential for injury to a patient should the treatment data be incorrectly uploaded to patient records.
Distribution
International Only Distribution -- Germany and Japan
Lot / Code Info
Part # 10568605
Root Cause
Software design (manufacturing process)
Action Taken
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.