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

Artis zee multi-purpose recalled by Siemens Medical Solutions USA

Siemens Medical Solutions USA is recalling Artis zee multi-purpose, distributed nationwide in the US. The recall was initiated on 20 Oct 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial Numbers: 159030 159034 159038 159032 159046 159054 159015 159058 159028 159037 159026 159042 159047 159025 159024 159021 159041 159049 159010 Expanded Recall 11/15/21: 159065

Quantity recalled19 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-0298-2022
FDA event ID: 88962
Recalling firm: Siemens Medical Solutions USA, Malvern, PA
Classification: Class II
Status: Terminated
Recall initiated: 20 Oct 2021
FDA classified: 24 Nov 2021
Reported: 1 Dec 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Imaging Equipment

Timeline

20 Oct 2021	Recall initiated by company
24 Nov 2021	Classified by FDA	+35 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

If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result in a short delay in procedure

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

Artis zee multi-purpose with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10094139

Where it was distributed

US Nationwide Distribution

Nationwide

Questions about this recall

Is Artis zee multi-purpose recalled?

Yes. Siemens Medical Solutions USA recalled Artis zee multi-purpose on 20 Oct 2021. The recall is Class II and its status is Terminated. Recall number Z-0298-2022.

Why was it recalled?

Which lots are affected?

Serial Numbers: 159030 159034 159038 159032 159046 159054 159015 159058 159028 159037 159026 159042 159047 159025 159024 159021 159041 159049 159010 Expanded Recall 11/15/21: 159065

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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