CLASS II Device recall · Reported 26 Feb 2020 · FDA Enforcement Report

Luminos dRF Max recalled by Siemens Medical Solutions USA

Siemens Medical Solutions USA is recalling Luminos dRF Max, distributed nationwide in the US. The recall was initiated on 8 Jan 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial Numbers 5043 5085 5825 5234 5862 5751 5810 5188 5352 5719 5803 5812 5920 5921 5209 5069 5086 5151 5299 5372 5611 5037 5072 5947 5049 5190 5892 5961 5364 5163 5919 5355 5902 5690 5767 5954 5884 5278 5963 5956 5682 5953 5634 5951 5120 5962

Quantity recalled46

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-1337-2020
FDA event ID: 84815
Recalling firm: Siemens Medical Solutions USA, Malvern, PA
Classification: Class II
Status: Terminated
Recall initiated: 8 Jan 2020
FDA classified: 20 Feb 2020
Reported: 26 Feb 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Imaging Equipment

Timeline

8 Jan 2020	Recall initiated by company
20 Feb 2020	Classified by FDA	+43 days
26 Feb 2020	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 software bug may lead to one image to be assigned to two different patients, which could potentially affect medical diagnosis.

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 dRF Max, model no. 10762471 - Product Usage: Luminos dRF Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. The system has medical applications ranging from gastrointestinal examinations to cranial, skeletal, thoracic and lung exposures as well as examinations of the urogenital tract.

Where it was distributed

US Nationwide distribution.

Nationwide

Questions about this recall

Why was it recalled?

A software bug may lead to one image to be assigned to two different patients, which could potentially affect medical diagnosis.

Which lots are affected?

Serial Numbers 5043 5085 5825 5234 5862 5751 5810 5188 5352 5719 5803 5812 5920 5921 5209 5069 5086 5151 5299 5372 5611 5037 5072 5947 5049 5190 5892 5961 5364 5163 5919 5355 5902 5690 5767 5954 5884 5278 5963 5956 5682 5953 5634 5951 5120 5962

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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 84815

This product is part of a recall event; the main page for the event is Ysio Max recalled by Siemens Medical Solutions USA.

Reported	Class	Recall	Company	Reason	Where
26 Feb 2020	CLASS II	Ysio Max recalled by Siemens Medical Solutions USA	Siemens Medical Solutions USA	Device Malfunction	Nationwide
26 Feb 2020	CLASS II	Luminos Agile Max recalled by Siemens Medical Solutions USA	Siemens Medical Solutions USA	Device Malfunction	Nationwide

Reported	Class	Recall	Company	Reason	Where
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All 2,336

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