Recall Z-0927-2009 ยท IYE Accelerator, Linear, Medical
Siemens Medical Solutions USA, Inc
Artiste MV SA Linear Accelerator with syngo RT Therapist Version 4.1 build 67 and build 122. Manufactured by Siemens Medical Solutions Oncology Care Systems, Concord, CA.
| Date | Jan 29, 2009 (initiated Oct 23, 2008) |
| Status | Terminated |
| Reason | If a plan contains a sequence of beams, including at least 1 ARC treatment beam and if during the setup stage of a beam following an ARC beam in the delivery sequence a termination occurs, and the user selects the immediate resumption feature, syngo RT Therapist Express systems will display and record a second delivery of a prior beam and not the delivery of the current beam in certain circumstanc |
| Root cause | Software design |
| Action | An Urgent Medical Device Customer Safety Letter dated October 23, 2008 was issued to consignees via certified mail. The letter identified the issue and preventive measures for consignees. Monitoring will be done via return cards. Follow-up to be conducted via telephone. |
| Quantity | 36 units |
| Distribution | Worldwide Distribution including USA and countries of Netherlands, Germany, Poland, Norway, Australia, Hungary, Belgium, New Zealand, France, Malaysia, Spain, and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072485 | ARTISTE MV SA Siemens Medical Solutions USA, Inc., Dec 27, 2007 |