CLASS II Device recall · Reported 31 Jul 2019 · FDA Enforcement Report

Axiom Artis FA recalled by Siemens Medical Solutions USA

Siemens Medical Solutions USA is recalling Axiom Artis FA, distributed nationwide in the US. The recall was initiated on 12 Jun 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial Numbers: 25328 25349 25382 25403

Quantity recalled4

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-2013-2019
FDA event ID: 83203
Recalling firm: Siemens Medical Solutions USA, Malvern, PA
Classification: Class II
Status: Terminated
Recall initiated: 12 Jun 2019
FDA classified: 22 Jul 2019
Reported: 31 Jul 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

12 Jun 2019	Recall initiated by company
22 Jul 2019	Classified by FDA	+40 days
31 Jul 2019	Published in enforcement report	+9 days

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

Reason for recall

A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue occurs sporadically; however, it may occur during an on-going 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

AXIOM Artis FA, Model Number 5904441

Where it was distributed

US Nationwide Distribution

Nationwide

Questions about this recall

Is Axiom Artis FA recalled?

Yes. Siemens Medical Solutions USA recalled Axiom Artis FA on 12 Jun 2019. The recall is Class II and its status is Terminated. Recall number Z-2013-2019.

Why was it recalled?

Which lots are affected?

Serial Numbers: 25328 25349 25382 25403

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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