CLASS II Device recall · Reported 8 Aug 2018 · FDA Enforcement Report

Somatom Scope recalled by Siemens Medical Solutions USA

Siemens Medical Solutions USA is recalling Somatom Scope (, distributed nationwide in the US. The recall was initiated on 1 Feb 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial No. 99329 98809 98886 99041 91203 91342 91475 98908 99019 99199 99248 99278 91286 98840 90872 90811 91486 98925 99049 91176 90939 91417 99258 91206 99296 91201 99295 99004 98991 90916 91090 99305 99179 91213 91402 91196 99244 90942 91133 91393 91506 99110 91494 91132 91204 98807 98875 99015 91418 91474 91108 91178 98926 91057 91179 91360 91367 99150 91310 91473 91396 99111 91263 91543 91190 91191 90907 91265 91416 99127 99255 99018 91355 91419 98814 91369 91222 91291 99274 99005 91376 91081 98855 91264 98788 90906 91325 91256 91038

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-2476-2018
FDA event ID: 79665
Recalling firm: Siemens Medical Solutions USA, Malvern, PA
Classification: Class II
Status: Terminated
Recall initiated: 1 Feb 2018
FDA classified: 28 Jul 2018
Reported: 8 Aug 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

1 Feb 2018	Recall initiated by company
28 Jul 2018	Classified by FDA	+177 days
8 Aug 2018	Published in enforcement report	+11 days

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

Reason for recall

A potential risk of unnecessary radiation exposure due to a software issue

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 Scope ( Model 10967666)

Where it was distributed

Nationwide

Questions about this recall

Is Somatom Scope ( recalled?

Yes. Siemens Medical Solutions USA recalled Somatom Scope ( on 1 Feb 2018. The recall is Class II and its status is Terminated. Recall number Z-2476-2018.

Why was it recalled?

A potential risk of unnecessary radiation exposure due to a software issue

Which lots are affected?

Serial No. 99329 98809 98886 99041 91203 91342 91475 98908 99019 99199 99248 99278 91286 98840 90872 90811 91486 98925 99049 91176 90939 91417 99258 91206 99296 91201 99295 99004 98991 90916 91090 99305 99179 91213 91402 91196 99244 90942 91133 91393 91506 99110 91494 91132 91204 98807 98875 99015 91418 91474 91108 91178 98926 91057 91179 91360 91367 99150 91310 91473 91396 99111 91263 91543 91190 91191 90907 91265 91416 99127 99255 99018 91355 91419 98814 91369 91222 91291 99274 99005 91376 91081 98855 91264 98788 90906 91325 91256 91038

Where was it sold?

Nationwide

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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