Reported Dec 1, 2021 · Terminated

SOMATOM Confidence with software syngo.CT VB20 Model #10590100

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 Confidence with software syngo.CT VB20 Model #10590100
Lot codes and dates
  • Serial Numbers

    104 of 104 codes

    • 100172
    • 100091
    • 100112
    • 100362
    • 100278
    • 100158
    • 100143
    • 100129
    • 100237
    • 100238
    • 100191
    • 100356
    • 100425
    • 100216
    • 100307
    • 100325
    • 100328
    • 100329
    • 100326
    • 100239
    • 100213
    • 100070
    • 100062
    • 100072
    • 100022
    • 100107
    • 100241
    • 100157
    • 100055
    • 100340
    • 100347
    • 100137
    • 100267
    • 100190
    • 100252
    • 100438
    • 100197
    • 100092
    • 100202
    • 100313
    • 100311
    • 100043
    • 100136
    • 100189
    • 100283
    • 100156
    • 100079
    • 100049
    • 100056
    • 100147
    • 100262
    • 100018
    • 100240
    • 100117
    • 100097
    • 100274
    • 100242
    • 100099
    • 100383
    • 100059
Amount recalled
104 units

This recall covers 17 products

The agency filed one notice per product. You are reading one of them; the other 16 are below.

4 more are in the archive.

Where it was sold

  • Nationwide

Why it was recalled

software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1, SP2, SP3, or SP4, may result in workflow interruptions resulting in the delay in diagnosis, the necessity for patient rescans, and/or the need for additional contrast media may occur

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

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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Notice updated Jan 16, 2024 · Data as of Sep 19, 5:35 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.