CLASS II ONGOING Device recall · Reported 1 Mar 2023 · FDA Enforcement Report

Luminos dRF recalled by Siemens Medical Solutions USA

Siemens Medical Solutions USA is recalling Luminos dRF, distributed nationwide in the US. The recall was initiated on 21 Dec 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI: N/A S/N: 4650 Expanded Recall 2/24/23: 4043 4051 4143 4156 4199 4201 4238 4252 4291 4323 4332 4342 4354 4372 4401 4430 4508 4600 4606 4637 4641 4683 4722 4724 4734

Quantity recalled1 unit; Expanded Recall: 25 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-1166-2023
FDA event ID: 91649
Recalling firm: Siemens Medical Solutions USA, Malvern, PA
Classification: Class II
Status: Ongoing
Recall initiated: 21 Dec 2022
FDA classified: 23 Feb 2023
Reported: 1 Mar 2023
Type: Voluntary: Firm initiated
Customers notified by: N/A
Reason category: Device Malfunction
Device type: Imaging Equipment

Timeline

21 Dec 2022	Recall initiated by company
23 Feb 2023	Classified by FDA	+64 days
1 Mar 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

Potential risk of collision with the ceiling, wall, or objects which may result in serious injury to staff or patients due to room configuration parameters of the system being set to default values

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 with software VD10- A diagnostic imaging system for radiographic and fluoroscopic studies Model Number: 10094200

Where it was distributed

US Nationwide distribution.

Nationwide

Questions about this recall

Is Luminos dRF recalled?

Yes. Siemens Medical Solutions USA recalled Luminos dRF on 21 Dec 2022. The recall is Class II and its status is Ongoing. Recall number Z-1166-2023.

Why was it recalled?

Potential risk of collision with the ceiling, wall, or objects which may result in serious injury to staff or patients due to room configuration parameters of the system being set to default values

Which lots are affected?

UDI: N/A S/N: 4650 Expanded Recall 2/24/23: 4043 4051 4143 4156 4199 4201 4238 4252 4291 4323 4332 4342 4354 4372 4401 4430 4508 4600 4606 4637 4641 4683 4722 4724 4734

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.

Reported	Class	Recall	Company	Reason	Where
8 Jul 2026Device	CLASS II	Artis icono ceiling recalled by Siemens Medical Solutions USA	Siemens Medical Solutions USA	Other	Nationwide
8 Jul 2026Device	CLASS II	Artis icono biplane recalled by Siemens Medical Solutions USA	Siemens Medical Solutions USA	Other	Nationwide
8 Jul 2026Device	CLASS II	Artis icono floor recalled by Siemens Medical Solutions USA	Siemens Medical Solutions USA	Other	Nationwide
8 Jul 2026Device	CLASS II	Artis icono ceiling recalled by Siemens Medical Solutions USA	Siemens Medical Solutions USA	Other	Nationwide
10 Jun 2026Device	CLASS II	Artis pheno recalled by Siemens Medical Solutions USA	Siemens Medical Solutions USA	Other	PA

Other Imaging Equipment recalls

All 2,336

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Medline Convenience Kits containing BD ChloraPrep Clear recalled	Medline Industries	Lead & Heavy Metals	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits: Ultrasound Breast Pack recalled	Medline Industries	Sterility	Nationwide
2 Sep 2026Device	CLASS II	Alphenix Models Infx-8000C Infx-8000F Infx-8000V This device is recalled	Canon Medical System, USA	Other	Nationwide
2 Sep 2026Device	CLASS II	Merge PACS and Merge OrthoPACS recalled by Merge Healthcare	Merge Healthcare	Labeling Errors	Nationwide
19 Aug 2026Device	CLASS II	Philips Azurion recalled by Philips Medical Systems	Philips Medical Systems Nederland B.v	Lead & Heavy Metals