Recall Z-1572-2011 ยท IYE Accelerator, Linear, Medical
Siemens Medical Solutions USA, Inc
MOSAIQ Oncology Information System Intended Use : Electronic Patient Records Management
| Date | Mar 7, 2011 (initiated Jan 11, 2011) |
| Status | Terminated |
| Reason | The potential for injury to a patient should the treatment data be incorrectly uploaded to patient records. |
| Root cause | 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 Safe |
| Quantity | 10 units |
| Distribution | International Only Distribution -- Germany and Japan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.