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SOMATOM Edge Plus-Computed tomography system Model 1026700

FDA Recall #Z-0474-2022 — Class II — November 19, 2021

Recall #Z-0474-2022 Date: November 19, 2021 Classification: Class II Status: Ongoing

Product Description

SOMATOM Edge Plus-Computed tomography system Model 1026700

Reason for Recall

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

Recalling Firm

Siemens Medical Solutions USA, Inc — Malvern, PA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

80 units

Distribution

US Nationwide distribution.

Code Information

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

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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