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Siemens Medical Solutions USA, Inc recalls Siemens Digital Linear Accelerators of type: ARTISTE MV System MEVATRON M2/Primus Mid-Energy PRIMUS PRIMUS HI ONCOR
Recalled May 1, 2019 · FDA recall Z-1204-2019 · Siemens Medical Solutions USA
Hazard
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. · FDA Class II
Units
120 US units
Sold at
Nationwide
Description
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.
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.
Manufacturer(s)
Siemens Medical Solutions USA, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →