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

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

Siemens Medical Solutions USA is recalling Siemens Artis zee 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.

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Lot, batch or date codesSerial Numbers: 153883 154041 153640 153772 154007 153870 153762 153700 153797 153827 153898 153779 153869 153952 153736 153829 153763 153998 153819 153758 153928 153760 153865 153903 153908 154592 153863 154785 154079 153988 153882 153831 153939 153875 153847 153930 153913 153890 153922 153992 153916 153975 154012 153947 154076 154086 154058 154028 154073 154048 154034 153987 154093 154090 154074 154052 154075 154406 154408 154459 154425 154423 154502 154084 154579 154546 154085 154471 154453 154097 154098 154544 154663 154576 154572 154560 154584 154571 154096 154514 154556 154509 154731 154536 154564 154739 154596 155147 154783 154653 154732 154687 154685 154779 154708 155150 154709 154715 154789 131011 131224 154800 131013 155119 131101 154814 131105 155122 131108 131110 155126 155131 155148 155189 131223 155195 131219 155203 155235 131231

Quantity recalled120

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-1896-2019
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 zee biplane-Interventional Fluoroscopic X-Ray System Model Number: 10094141

Where it was distributed

Nationwide

Questions about this recall

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

Yes. Siemens Medical Solutions USA recalled Siemens Artis zee biplane-Interventional Fluoroscopic X-Ray System on 6 Jun 2019. The recall is Class II and its status is Terminated. Recall number Z-1896-2019.

Why was it recalled?

Which lots are affected?

Serial Numbers: 153883 154041 153640 153772 154007 153870 153762 153700 153797 153827 153898 153779 153869 153952 153736 153829 153763 153998 153819 153758 153928 153760 153865 153903 153908 154592 153863 154785 154079 153988 153882 153831 153939 153875 153847 153930 153913 153890 153922 153992 153916 153975 154012 153947 154076 154086 154058 154028 154073 154048 154034 153987 154093 154090 154074 154052 154075 154406 154408 154459 154425 154423 154502 154084 154579 154546 154085 154471 154453 154097 154098 154544 154663 154576 154572 154560 154584 154571 154096 154514 154556 154509 154731 154536 154564 154739 154596 155147 154783 154653 154732 154687 154685 154779 154708 155150 154709 154715 154789 131011 131224 154800 131013 155119 131101 154814 131105 155122 131108 131110 155126 155131 155148 155189 131223 155195 131219 155203 155235 131231

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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