CLASS II Device recall · Reported 21 Aug 2019 · FDA Enforcement Report

Somatom Definition Edge recalled by Siemens Medical Solutions USA

Siemens Medical Solutions USA is recalling Somatom Definition Edge, 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: 83904 83931 83834 83746 83811 83915 83801 83767 83880 83899 83852 83798 83837 83878 83832 83871 83903 83808 83763 75475 83732 83752 83382 83845 83846 83749 83847 83786 83842 83775 83796 94801 83768 83909 83875 83859 83928 83826 83754 83913 83896 83790 83824 83898 83810 83886 83758 83901 83914 83823

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-2269-2019
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 Definition Edge, Model Number 10590000 - 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 Definition Edge recalled?

Yes. Siemens Medical Solutions USA recalled Somatom Definition Edge on 3 Jul 2019. The recall is Class II and its status is Terminated. Recall number Z-2269-2019.

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: 83904 83931 83834 83746 83811 83915 83801 83767 83880 83899 83852 83798 83837 83878 83832 83871 83903 83808 83763 75475 83732 83752 83382 83845 83846 83749 83847 83786 83842 83775 83796 94801 83768 83909 83875 83859 83928 83826 83754 83913 83896 83790 83824 83898 83810 83886 83758 83901 83914 83823

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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