Recall – Digital Linear Accelerator software error may lead to injury

Company: Siemens Medical Solutions USA, Inc
Date of Enforcement Report: 5/1/2019
Class II:

PRODUCT

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 11.0.400 and higher.

Recall Number: Z-1204-2019

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.

RECALLING FIRM/MANUFACTURER

Siemens Medical Solutions USA, Inc. on 3/20/2018. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
120 US units

DISTRIBUTION

US Nationwide

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