CLASS II Device recall · Reported 21 Nov 2018 · FDA Enforcement Report

Artis Q.zen biplane with Material recalled

Siemens Medical Solutions USA is recalling Artis Q.zen biplane with Material 10848355 - a Angiographic x-ray system, distributed nationwide in the US. The recall was initiated on 19 Oct 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial Numbers: Serial 123202 123211 123208 123209 123206 123207 123219 123205 123201 123055 123056 123216 123200 123212

Quantity recalled15

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-0459-2019
FDA event ID: 81514
Recalling firm: Siemens Medical Solutions USA, Malvern, PA
Classification: Class II
Status: Terminated
Recall initiated: 19 Oct 2018
FDA classified: 13 Nov 2018
Reported: 21 Nov 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Imaging Equipment

Timeline

19 Oct 2018	Recall initiated by company
13 Nov 2018	Classified by FDA	+25 days
21 Nov 2018	Published in enforcement report	+8 days

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

Reason for recall

Vibrations of the C-arm of the plane B may result in reduced image quality caused by the screw connection to the C-arm in the ceiling support

Product as listed by the FDA

ARTIS Q.zen biplane with Material 10848355 - a Angiographic x-ray system Product Usage: Artis zee is a dedicated angiography system developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Artis zee includes cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis zee can also support the acquisition of position triggered imaging for spatial data synthesis.

Where it was distributed

US Nationwide Distribution

Nationwide

Questions about this recall

Why was it recalled?

Vibrations of the C-arm of the plane B may result in reduced image quality caused by the screw connection to the C-arm in the ceiling support

Which lots are affected?

Serial Numbers: Serial 123202 123211 123208 123209 123206 123207 123219 123205 123201 123055 123056 123216 123200 123212

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 81514

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

Reported	Class	Recall	Company	Reason	Where
21 Nov 2018	CLASS II	Artis Q biplane with Material recalled by Siemens Medical Solutions USA	Siemens Medical Solutions USA	Other	Nationwide
21 Nov 2018	CLASS II	Artis zee biplane systems with Material recalled	Siemens Medical Solutions USA	Other	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

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