CLASS II Device recall · Reported 1 Dec 2021 · FDA Enforcement Report

Artis Q ceiling recalled by Siemens Medical Solutions USA

Siemens Medical Solutions USA is recalling Artis Q ceiling, distributed nationwide in the US. The recall was initiated on 20 Oct 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial Numbers: 110088 110059 110103 110035 110046 110005 110058 110056 110062 109523 109645 110067 110095 110051 110001 110020 110007 110093 110069 110075 109627 110042 110043 110048 110061 110063 110064 110032 110047 110102 110039 110040 110023 110065 110052 110018 110072 110081 110036 110054 110053 110044 110031 110016 110037 110077 109497 110079 110099 110027 110049 110066 110024 110017 110025 110100 110083 110091 110006 110055 110026 110022 110000 133501 110057 110104 110041 Expanded Recall 11/15/21: 110096 110014

Quantity recalled67 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-0301-2022
FDA event ID: 88962
Recalling firm: Siemens Medical Solutions USA, Malvern, PA
Classification: Class II
Status: Terminated
Recall initiated: 20 Oct 2021
FDA classified: 24 Nov 2021
Reported: 1 Dec 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Imaging Equipment

Timeline

20 Oct 2021	Recall initiated by company
24 Nov 2021	Classified by FDA	+35 days
1 Dec 2021	Published in enforcement report	+7 days

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

Reason for recall

If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result in a short delay in 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

Artis Q ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10848281

Where it was distributed

US Nationwide Distribution

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

Serial Numbers: 110088 110059 110103 110035 110046 110005 110058 110056 110062 109523 109645 110067 110095 110051 110001 110020 110007 110093 110069 110075 109627 110042 110043 110048 110061 110063 110064 110032 110047 110102 110039 110040 110023 110065 110052 110018 110072 110081 110036 110054 110053 110044 110031 110016 110037 110077 109497 110079 110099 110027 110049 110066 110024 110017 110025 110100 110083 110091 110006 110055 110026 110022 110000 133501 110057 110104 110041 Expanded Recall 11/15/21: 110096 110014

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

9 other products · FDA event 88962

This product is part of a recall event; the main page for the event is Artis Q.zen ceiling recalled by Siemens Medical Solutions USA.

Reported	Class	Recall	Company	Reason	Where
1 Dec 2021	CLASS II	Artis Q.zen ceiling recalled by Siemens Medical Solutions USA	Siemens Medical Solutions USA	Device Malfunction	Nationwide
1 Dec 2021	CLASS II	Artis Q floor recalled by Siemens Medical Solutions USA	Siemens Medical Solutions USA	Device Malfunction	Nationwide
1 Dec 2021	CLASS II	Artis Q biplane recalled by Siemens Medical Solutions USA	Siemens Medical Solutions USA	Device Malfunction	Nationwide
1 Dec 2021	CLASS II	Artis zee floor recalled by Siemens Medical Solutions USA	Siemens Medical Solutions USA	Device Malfunction	Nationwide
1 Dec 2021	CLASS II	Artis zee ceiling recalled by Siemens Medical Solutions USA	Siemens Medical Solutions USA	Device Malfunction	Nationwide
1 Dec 2021	CLASS II	Artis Q.zen biplane recalled by Siemens Medical Solutions USA	Siemens Medical Solutions USA	Device Malfunction	Nationwide
1 Dec 2021	CLASS II	Artis zee biplane recalled by Siemens Medical Solutions USA	Siemens Medical Solutions USA	Device Malfunction	Nationwide
1 Dec 2021	CLASS II	Artis Q.zen floor recalled by Siemens Medical Solutions USA	Siemens Medical Solutions USA	Device Malfunction	Nationwide
1 Dec 2021	CLASS II	Artis zee multi-purpose recalled by Siemens Medical Solutions USA	Siemens Medical Solutions USA	Device Malfunction	Nationwide

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	Packaging Defects	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 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 Nederl	Potency & Assay