Recall Z-0907-2011 ยท IYE Accelerator, Linear, Medical
Siemens Medical Solutions, Oncology Care Systems, 4040 Nelson Ave., Concord, CA 94510
ARTISTE and ONCOR Digital Linear Accelerators configured with the 160 leaf Multi-Leaf Collimator (MLC) and MEVATRON and PRIMUS Digital Linear Accelerators configured with the High Performance Defining Collimator (HPD); Product is manufactured by Kemnath, Germany-Siemens AG OCS and Siemens AG, Erlangen, Germany-Siemens AG OCS and distributed by Siemens Medical Solutions, Oncology Care Systems, Conc
| Date | Jan 18, 2011 (initiated Aug 13, 2010) |
| Status | Terminated |
| Reason | The potential safety issue with the 160MLC or the HPD collimator of mechanical noises and/or sticking of the collimator when rotating the collimator. The potential for mistreatment to a patient should the collimator not be aligned correctly if the bearings are damaged. |
| Root cause | Pending |
| Action | Urgent: Medical Device Correction Safety Advisory Notice letters were sent by certified mail commencing August 3, 2010. The letter described the issue and when it occurs, the measures users could take, and how Siemens would address the issue. It is recommended that customers include a check of the field alignment at 90 and 270 degrees gantry angle in the daily check prior to start of patient treatments. A copy of the Safety Advisory Notice should be included in the Owner's Manual and questions should be directed towards the local Siemens Service Engineer or Application Specialist. |
| Quantity | 1167 |
| Distribution | Worldwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.