Reported Jan 19, 2022 · Ongoing

SOMATOM Edge Plus-Computed tomography system Model 1026700

Siemens Medical Solutions USA, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Siemens Medical Solutions USA, Inc · 40 Liberty Blvd · Malvern, PA · 19355-1418

Is this the product you have?

  • SOMATOM Edge Plus-Computed tomography system Model 1026700
Lot codes and dates
  • Serial Numbers

    80 of 80 codes

    • 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
  • UDIUDI 04056869006949
Amount recalled
80 units

This recall covers 4 products

The agency filed one notice per product. You are reading one of them; the other 3 are below.

Where it was sold

  • Nationwide

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:34 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.