PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: October 5, 2016 Initiated: July 26, 2016 #Z-2876-2016

Product Description

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.

Reason for Recall

Software patch installation to address several safety issues.

Details

Units Affected
103 accelerators
Distribution
Nationwide distribution
Location
Malvern, PA

Frequently Asked Questions

What product was recalled?
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.. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 103 accelerators.
Why was this product recalled?
Software patch installation to address several safety issues.
Which agency issued this recall?
This recall was issued by the FDA Devices on October 5, 2016. Severity: Moderate. Recall number: Z-2876-2016.