CLASS II ONGOING Device recall · Reported 14 Jan 2026 · FDA Enforcement Report

Luminos Lotus Max recalled by Siemens Medical Solutions USA

Siemens Medical Solutions USA is recalling Luminos Lotus Max. The recall was initiated on 5 Dec 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes(01)04056869269931(21)10330

Quantity recalledU.S.: 1, OUS: 95

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-0999-2026
FDA event ID: 98230
Recalling firm: Siemens Medical Solutions USA, Malvern, PA
Classification: Class II
Status: Ongoing
Recall initiated: 5 Dec 2025
FDA classified: 8 Jan 2026
Reported: 14 Jan 2026
Type: FDA Mandated
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

5 Dec 2025	Recall initiated by company
8 Jan 2026	Classified by FDA	+34 days
14 Jan 2026	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

A potential issue associated with LUMINOS Lotus Max and Luminos dRF Max systems with software version VF11 with bucky wall stand for mobile detectors and without ceiling stand .When switching quickly between organ programs (OGPs) the collimation may be incorrect.

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

LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471

Where it was distributed

U.S. and OUS

Questions about this recall

Is Luminos Lotus Max recalled?

Yes. Siemens Medical Solutions USA recalled Luminos Lotus Max on 5 Dec 2025. The recall is Class II and its status is Ongoing. Recall number Z-0999-2026.

Why was it recalled?

Which lots are affected?

(01)04056869269931(21)10330

Where was it sold?

U.S. and OUS

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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