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

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

Siemens Medical Solutions USA is recalling Siemens Artis Q biplane---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: 121013 121057 121056 121058 121006 121185 121016 121027 121020 121321 121448 121040 121049 121015 121094 121082 121089 121383 121144 121319 121137 121085 121155 121193 121136 121165 121140 121141 121151 121168 121169 121154 121211 121188 121415 121183 121209 121187 121309 121200 121313 121206 121361 121366 121359 121393 121301 121407 121406 121352 121379 121364 121342 121471 121520 121411 121412 121402 121430 121502 121421 121472 121460 121457 121515 121444 121516 121510 121491 121525 121530 121527

Quantity recalled73

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-1900-2019
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 biplane---Interventional Fluoroscopic X-Ray System Model Number: 10848282

Where it was distributed

Nationwide

Questions about this recall

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

Yes. Siemens Medical Solutions USA recalled Siemens Artis Q biplane---Interventional Fluoroscopic X-Ray System on 6 Jun 2019. The recall is Class II and its status is Terminated. Recall number Z-1900-2019.

Why was it recalled?

Which lots are affected?

Serial Numbers: 121013 121057 121056 121058 121006 121185 121016 121027 121020 121321 121448 121040 121049 121015 121094 121082 121089 121383 121144 121319 121137 121085 121155 121193 121136 121165 121140 121141 121151 121168 121169 121154 121211 121188 121415 121183 121209 121187 121309 121200 121313 121206 121361 121366 121359 121393 121301 121407 121406 121352 121379 121364 121342 121471 121520 121411 121412 121402 121430 121502 121421 121472 121460 121457 121515 121444 121516 121510 121491 121525 121530 121527

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

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