Recall Z-2876-2016 ยท IYE Accelerator, Linear, Medical
Siemens Medical Solutions USA, Inc
ARTISTE, Accelerator, Linear, Medical The intended use of the SIEMENS branded ARTISTETM family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer.
| Date | Jul 26, 2016 |
| Status | Terminated |
| Reason | Software patch installation to address several safety issues. |
| Root cause | Software design |
| Action | Siemens sent a Field Safety Notice to all affected customers informing them of a new software patch that they plan to install to address software issues. Customers were advised to notify anyone at their organization who should be aware of the information contained in the Notice. Customers were also advised to include the Field Safety Notice in their System Owner Manual, chapter "Safety Advisory Letters" where it should remain. For questions regarding this recall call 610-219-4834. |
| Quantity | 103 accelerators |
| Distribution | Nationwide distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K103606 | ARTISTE SOLUTION WITH SYS_VB50 UPDATE Siemens Medical Solutions USA, Inc., Apr 15, 2011 |