Siemens Medical Solutions USA, Inc: SOMATOM Edge Plus-Computed tomography system Model 1026700

Is my product affected?

SOMATOM Edge Plus-Computed tomography system Model 1026700

• UPC 04056869006949

Check against the official notice below — it lists the full affected range.

What happened

Siemens Medical Solutions USA, Inc. is recalling 80 SOMATOM Edge Plus computed tomography systems (model 1026700) distributed nationwide that contain software version VB20_SP5. This software version can cause degradation of head image quality, which creates a potential risk of patient misdiagnosis. The affected units can be identified by their serial numbers, which are listed in the recall documentation.

The recall record does not specify a remedy or corrective action for affected consumers to take.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Software version VB20_SP5 my lead to a relevant degradation of head image quality, a potential risk to patients is misdiagnosis.

Details from the source

Reason for recall: Software version VB20_SP5 my lead to a relevant degradation of head image quality, a potential risk to patients is misdiagnosis. Distribution: US Nationwide distribution. Quantity: 80 units Lot/code info: Serial Numbers: 122022 122185 122098 122062 122099 122121 122146 122054 122082 122080 122020 122164 122116 122008 122036 122029 122044 122172 122074 122075 122049 122194 122141 122167 122156 122183 122081 122126 122129 122090 122130 122179 122089 122085 122037 122009 122163 122177 122066 122064 122038 122161 122132 122171 122153 122168 122158 122144 122063 122086 122035 122041 122112 122114 122107 122101 122108 122109 122162 122187 122174 122125 122178 122011 122182 122052 122034 122057 122145 122147 122050 122106 122189 122180 122061 122051 122166 122170 122092 122004 UDI: UDI 04056869006949

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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