CLASS II Device recall · Reported 25 Nov 2020 · FDA Enforcement Report

Artis Q.zen ceiling recalled by Siemens Medical Solutions USA

Siemens Medical Solutions USA is recalling Artis Q.zen ceiling, distributed nationwide in the US. The recall was initiated on 21 Oct 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial numbers 109762 111158 124344 111161

Quantity recalled26 distributed worldwide (4 in US)

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-0469-2021
FDA event ID: 86660
Recalling firm: Siemens Medical Solutions USA, Malvern, PA
Classification: Class II
Status: Terminated
Recall initiated: 21 Oct 2020
FDA classified: 18 Nov 2020
Reported: 25 Nov 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Imaging Equipment

Timeline

21 Oct 2020	Recall initiated by company
18 Nov 2020	Classified by FDA	+28 days
25 Nov 2020	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

Some electronic components within the generator were equipped with an incorrect protection diode. As a result, protection against overvoltage may be inadequate, and the system may not function properly in the event an overvoltage situation occurs.

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 zee floor, Artis Q ceiling, Artis Q.zen ceiling. Image-Intensified Fluoroscopic X-Ray System. Material numbers 10848281, 10848354, 10094135, 10848354 - Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.

Where it was distributed

Worldwide distribution - US Nationwide distribution including in the states of AR, CA, IA, IL and the countries of China, Germany, India, Indonesia, Italy, Japan, Philippines, Saudi Arabia, South Korea, Taiwan, Turkey, and United Kingdom.

Nationwide Arkansas California Iowa Illinois

Questions about this recall

Why was it recalled?

Which lots are affected?

Serial numbers 109762 111158 124344 111161

Where was it sold?

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.

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

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