CLASS II Device recall · Reported 21 Aug 2019 · 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 3 Jul 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial Numbers: 105081 105152 105128 105123 105105 105150 105096 105047 105115 105086 105165 105121 105103 105141 105118 105109 105116 105080

Quantity recalledN/A

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-2271-2019
FDA event ID: 83377
Recalling firm: Siemens Medical Solutions USA, Malvern, PA
Classification: Class II
Status: Terminated
Recall initiated: 3 Jul 2019
FDA classified: 14 Aug 2019
Reported: 21 Aug 2019
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Device Malfunction
Device type: Imaging Equipment

Timeline

3 Jul 2019	Recall initiated by company
14 Aug 2019	Classified by FDA	+42 days
21 Aug 2019	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

Potential for four safety-related software issues impacting systems utilizing syngo.CT software version VB10A which may result in a scan abort.

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, Model Number 10431700 - Product Usage: Computed tomography systems intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by a trained physician as an aid in diagnosis. The images delivered by the system can be used by trained staff as an aid in diagnosis, treatment preparation and radiation therapy planning. These CT systems can be used for low dose lunch cancer screening in high risk populations (as defined by professional medical societies).

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 3 Jul 2019. The recall is Class II and its status is Terminated. Recall number Z-2271-2019.

Why was it recalled?

Potential for four safety-related software issues impacting systems utilizing syngo.CT software version VB10A which may result in a scan abort.

Which lots are affected?

Serial Numbers: 105081 105152 105128 105123 105105 105150 105096 105047 105115 105086 105165 105121 105103 105141 105118 105109 105116 105080

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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