CLASS II Device recall · Reported 10 Jul 2019 · FDA Enforcement Report

Siemens Artis Q zeego ---Interventional Fluoroscopic X-Ray System recalled

Siemens Medical Solutions USA is recalling Siemens Artis Q zeego ---Interventional Fluoroscopic X-Ray System, distributed nationwide in the US. The recall was initiated on 6 Jun 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial Numbers: 117309 117125

Quantity recalled2

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-1901-2019
FDA event ID: 83082
Recalling firm: Siemens Medical Solutions USA, Malvern, PA
Classification: Class II
Status: Terminated
Recall initiated: 6 Jun 2019
FDA classified: 28 Jun 2019
Reported: 10 Jul 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Imaging Equipment

Timeline

6 Jun 2019	Recall initiated by company
28 Jun 2019	Classified by FDA	+22 days
10 Jul 2019	Published in enforcement report	+12 days

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

Reason for recall

Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movable, the potential exists for individual screws of the screwed connection joining the pivot bearing to the ceiling-mounted support to work loose or snap off, can result in severe injuries to patients and operating personnel

Product as listed by the FDA

Siemens Artis Q zeego ---Interventional Fluoroscopic X-Ray System Model Number: 10848283

Where it was distributed

Nationwide

Questions about this recall

Is Siemens Artis Q zeego ---Interventional Fluoroscopic X-Ray System recalled?

Yes. Siemens Medical Solutions USA recalled Siemens Artis Q zeego ---Interventional Fluoroscopic X-Ray System on 6 Jun 2019. The recall is Class II and its status is Terminated. Recall number Z-1901-2019.

Why was it recalled?

Which lots are affected?

Serial Numbers: 117309 117125

Where was it sold?

Nationwide

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

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