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Siemens Medical Solutions USA, Inc recalls AXIOM Artis BC, Model Number 5904649
Recalled July 31, 2019 · FDA recall Z-2015-2019 · Siemens Medical Solutions USA
Hazard
A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue occurs sporadically; however, it may occur during an on-going procedure. · FDA Class II
Units
6
Sold at
US Nationwide Distribution
Description
A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue occurs sporadically; however, it may occur during an on-going procedure.
Product
AXIOM Artis BC, Model Number 5904649
Manufacturer(s)
Siemens Medical Solutions USA, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →