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Siemens Medical Solutions USA, Inc recalls SOMATOM Edge Plus-Computed tomography system Model 1026700
Recalled January 19, 2022 · FDA recall Z-0474-2022 · Siemens Medical Solutions USA
Hazard
Software version VB20_SP5 my lead to a relevant degradation of head image quality, a potential risk to patients is misdiagnosis. · FDA Class II
Units
80 units
Sold at
US Nationwide distribution.
Description
Software version VB20_SP5 my lead to a relevant degradation of head image quality, a potential risk to patients is misdiagnosis.
Product
SOMATOM Edge Plus-Computed tomography system Model 1026700
Manufacturer(s)
Siemens Medical Solutions USA, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →