CLASS II Device recall · Reported 1 Dec 2021 · FDA Enforcement Report

Somatom Drive recalled by Siemens Medical Solutions USA

Siemens Medical Solutions USA is recalling Somatom Drive, distributed nationwide in the US. The recall was initiated on 30 Aug 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial Numbers: 105081 105478 105152 105471 105315 105484 105182 105228 105207 105128 105123 105241 105105 105020 105063 105035 105022 105045 105052 105150 105485 105302 105472 105096 105477 105047 105023 105180 105115 105086 105295 105398 105051 105196 105445 105336 105383 105402 105202 105046 105109 105244 105498 105466 105461 105165 105060 105464 105103 105121 105141 105344 105066 105503 105118 105321 105184 105245 105339 105240 105507 105280 105440 105254 105403 105354 105427 105208 105012 105116 105363 105294 105080 105018 105237

Quantity recalled75 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0287-2022
FDA event ID: 88888
Recalling firm: Siemens Medical Solutions USA, Malvern, PA
Classification: Class II
Status: Terminated
Recall initiated: 30 Aug 2021
FDA classified: 24 Nov 2021
Reported: 1 Dec 2021
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Device Malfunction
Device type: Medical Software

Timeline

30 Aug 2021	Recall initiated by company
24 Nov 2021	Classified by FDA	+86 days
1 Dec 2021	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

SOMATOM Drive with software syngo.CT VB20 Model #10431700

Where it was distributed

US Nationwide distribution.

Nationwide

Questions about this recall

Is Somatom Drive recalled?

Yes. Siemens Medical Solutions USA recalled Somatom Drive on 30 Aug 2021. The recall is Class II and its status is Terminated. Recall number Z-0287-2022.

Why was it recalled?

Which lots are affected?

Serial Numbers: 105081 105478 105152 105471 105315 105484 105182 105228 105207 105128 105123 105241 105105 105020 105063 105035 105022 105045 105052 105150 105485 105302 105472 105096 105477 105047 105023 105180 105115 105086 105295 105398 105051 105196 105445 105336 105383 105402 105202 105046 105109 105244 105498 105466 105461 105165 105060 105464 105103 105121 105141 105344 105066 105503 105118 105321 105184 105245 105339 105240 105507 105280 105440 105254 105403 105354 105427 105208 105012 105116 105363 105294 105080 105018 105237

Where was it sold?

US Nationwide distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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