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Siemens Medical Solutions USA, Inc recalls ARTIS Pheno Interventional Fluoroscopic X-Ray System, Model Number 10849000
Recalled September 26, 2018 · FDA recall Z-3190-2018 · Siemens Medical Solutions USA
Hazard
Temperature of the detector may fall out of its designed working range (cool down) due to incorrectly configured temperature control unit. This unintentional system behavior may occur while the unit is powered down for long periods (e.g. at night). · FDA Class II
Units
429 total
Sold at
US nationwide distribution.
Description
Temperature of the detector may fall out of its designed working range (cool down) due to incorrectly configured temperature control unit. This unintentional system behavior may occur while the unit is powered down for long periods (e.g. at night).
Product
ARTIS Pheno Interventional Fluoroscopic X-Ray System, Model Number 10849000
Manufacturer(s)
Siemens Medical Solutions USA, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →