CLASS II ONGOING Device recall · Reported 25 Jan 2023 · FDA Enforcement Report

Axiom Luminos Agile recalled by Siemens Medical Solutions USA

Siemens Medical Solutions USA is recalling Axiom Luminos Agile. The recall was initiated on 9 Dec 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll serial numbers for AXIOM Luminos Agile, Material #10502200 (no UDI)

Quantity recalled271 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-1001-2023
FDA event ID: 91383
Recalling firm: Siemens Medical Solutions USA, Malvern, PA
Classification: Class II
Status: Ongoing
Recall initiated: 9 Dec 2022
FDA classified: 19 Jan 2023
Reported: 25 Jan 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

9 Dec 2022	Recall initiated by company
19 Jan 2023	Classified by FDA	+41 days
25 Jan 2023	Published in enforcement report	+6 days

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

Reason for recall

There is potential for the footrest to detach from the patient table during use.

Product as listed by the FDA

AXIOM Luminos Agile

Where it was distributed

Worldwide distribution

Questions about this recall

Is Axiom Luminos Agile recalled?

Yes. Siemens Medical Solutions USA recalled Axiom Luminos Agile on 9 Dec 2022. The recall is Class II and its status is Ongoing. Recall number Z-1001-2023.

Why was it recalled?

There is potential for the footrest to detach from the patient table during use.

Which lots are affected?

All serial numbers for AXIOM Luminos Agile, Material #10502200 (no UDI)

Where was it sold?

Worldwide 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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