Reported Oct 7, 2020 · Terminated

Software versions syngo.CT VB20 or VB20_SP1 in the following systems: SOMATOM Force (Model #10742326) SOMATOM…

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

Is this the product you have?

  • Software versions syngo.CT VB20 or VB20_SP1
  • in the following systemsSOMATOM Force (Model #10742326) SOMATOM Definition As (Model #8098027) SOMATOM Definition Edge (Model #10590000) SOMATOM Definition Flash (Model #10430603) SOMATOM Drive (Model #10431700) SOMATOM Confidence (Model #10590100) SOMATOM Edge Plus (Model #10267000)
Lot codes and dates
  • Software versions syngo CT VB20 and syngo CT VB20_SP1
  • Serial Numbers

    728 of 728 codes

    • 59812
    • 59819
    • 59820
    • 59823
    • 59825
    • 59828
    • 64036
    • 64051
    • 64064
    • 64066
    • 64104
    • 64132
    • 64148
    • 64160
    • 64211
    • 64218
    • 64221
    • 64347
    • 64407
    • 64427
    • 64498
    • 64500
    • 64501
    • 64516
    • 64519
    • 64605
    • 64677
    • 64707
    • 64712
    • 64732
    • 64785
    • 64869
    • 64924
    • 64999
    • 65022
    • 65157
    • 65159
    • 65186
    • 65229
    • 65235
    • 65238
    • 65247
    • 65251
    • 65297
    • 65299
    • 65370
    • 65371
    • 65382
    • 65443
    • 65478
    • 65493
    • 65501
    • 65515
    • 65556
    • 65586
    • 65607
    • 65611
    • 65652
    • 65667
    • 65728
    ***Added 10/1/20*** 75774
  • Added 10/31/2095389 95280 59814
Amount recalled
767 distributed in U.S.

Where it was sold

  • Nationwide

Why it was recalled

Sporadic problems with the current software may result in scanning workflow interruptions and unexpected user notifications causing delay in diagnosis or patient rescan

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

Notice updated Mar 9, 2021 · Data as of Sep 19, 6:16 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.