Recall Z-1204-2019 ยท IYE Accelerator, Linear, Medical
Siemens Medical Solutions USA, Inc
Siemens Digital Linear Accelerators of type: ARTISTE MV System MEVATRON M2/Primus Mid-Energy PRIMUS PRIMUS HI ONCOR Impression ONCOR Impression Plus ONCOR Avant Garde ONCOR Expression ARTISTE, ONCOR, and PRIMUS running the following: Control Console from software version 13.0.302 and higher; Control Console from software version 9.2.400 and higher; and Control Console from software version 11.0.4
| Date | Mar 20, 2019 |
| Status | Terminated |
| Reason | Advisory issued not to disable or bypass the AMP function. Disabling or bypassing the AMP function for reasons of comfort is not advisable may lead to patient or user injury due to collision with LINAC equipment disabling the Auto Field Sequence (AFS) Automatic Motion Protection (AMP) function implemented at the control of the Digital Linear Accelerator. |
| Root cause | Use error |
| Action | Siemens Healthcare issued CUSTOMER SAFETY ADVISORY NOTICE to accounts via electronic mail addresses and/or USPS certified mail on March 20. Letter identifies the issue , action to take: due to potential for collisions of the LINAC equipment with patients, Siemens Healthcare GmbH advises customers to not to disable or bypass the AMP function. Customers who decide to disable or bypass the AMP function, do so at their own responsibility, duly weighing patient benefit and risk. Disabling or bypassing for reasons of comfort is not advisable. Notify and instruct accordingly all the staff at your or |
| Quantity | 120 US units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031764 | ONCOR AVANT-GARDE WITH COHERENCE WORKSPACES Siemens Medical Solutions USA, Inc., Sep 5, 2003 |
| K060226 | ONCOR EXPRESSION Siemens Medical Solutions USA, Inc., Mar 15, 2006 |
| K072485 | ARTISTE MV SA Siemens Medical Solutions USA, Inc., Dec 27, 2007 |
| K121295 | ARTISTETM SOLUTION WITH SYS VCIO Siemens Medical Solutions USA, Inc., Jun 27, 2012 |
| K993425 | PRIMUS Siemens Medical Solutions USA, Inc., Nov 26, 1999 |