CLASS II Device recall · Reported 6 Sep 2017 · FDA Enforcement Report

Artis zee/zeego and Artis Q/Q.zen system, x-ray recalled

Siemens Medical Solutions USA is recalling Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic Axiom Artis zee and Q/Q.zen, distributed nationwide in the US. The recall was initiated on 18 Feb 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesArtis zee floor- Serial number: 137623 137165 137282 137618 137226 136513 136562 137118 137103 137461 137510 137193 137479 137425 137540 137532 137314 137295 137582 137592 136568 137075 137130 137188 137131 137146 136607 136579 137388 137470 124007 124015 137347 137638 137389 137595 137245 137620 137335 137617 137607 136500 136515 137369 137569 136479 137119 124051 136488 136550 136450 136408 136547 136508 136517 124039 137360 137311 137320 136586 136520 137521 137639 136548 137645 137395 137093 137018 136483 136555 137421 137551 137471 137591 137239 137438 136614 137384 137011 136567 124034 137403 137391 137296 137458 136970 137229 137112 136561 136505 124006 137244 137231 137219 137513 137224 137217 136979 137329 137328 136557 136558 137511 136503 137297 136582 136570 137567 136459 136518 136609 136594 124056 137579 137218 137518

Quantity recalled986 units in USA

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-3095-2017
FDA event ID: 77908
Recalling firm: Siemens Medical Solutions USA, Malvern, PA
Classification: Class II
Status: Terminated
Recall initiated: 18 Feb 2016
FDA classified: 29 Aug 2017
Reported: 6 Sep 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Imaging Equipment

Timeline

18 Feb 2016	Recall initiated by company
29 Aug 2017	Classified by FDA	+558 days
6 Sep 2017	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

Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. Loss of coolant can results in a cooling system failure and subsequent system failure. This leek can occur sporadically in affected systems.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen 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. Procedures that can be performed with the AXIOM Artis-zee/zeego and Q/Q.zen family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. AXIOM Artis zee/zeego and Q/Q.zen can also support the acquisition of position triggered imaging for spatial data synthesis

Where it was distributed

Nationwide Distribution

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

Artis zee floor- Serial number: 137623 137165 137282 137618 137226 136513 136562 137118 137103 137461 137510 137193 137479 137425 137540 137532 137314 137295 137582 137592 136568 137075 137130 137188 137131 137146 136607 136579 137388 137470 124007 124015 137347 137638 137389 137595 137245 137620 137335 137617 137607 136500 136515 137369 137569 136479 137119 124051 136488 136550 136450 136408 136547 136508 136517 124039 137360 137311 137320 136586 136520 137521 137639 136548 137645 137395 137093 137018 136483 136555 137421 137551 137471 137591 137239 137438 136614 137384 137011 136567 124034 137403 137391 137296 137458 136970 137229 137112 136561 136505 124006 137244 137231 137219 137513 137224 137217 136979 137329 137328 136557 136558 137511 136503 137297 136582 136570 137567 136459 136518 136609 136594 124056 137579 137218 137518

Where was it sold?

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

11 other products · FDA event 77908

This product is part of a recall event; the main page for the event is Artis zee/zeego and Artis Q/Q.zen system, x-ray recalled.

Reported	Class	Recall	Company	Reason	Where
6 Sep 2017	CLASS II	Artis zee/zeego and Artis Q/Q.zen system, x-ray recalled	Siemens Medical Solutions USA	Packaging Defects	Nationwide
6 Sep 2017	CLASS II	Artis zee/zeego and Artis Q/Q.zen system, x-ray recalled	Siemens Medical Solutions USA	Packaging Defects	Nationwide
6 Sep 2017	CLASS II	Artis zee/zeego and Artis Q/Q.zen system, x-ray recalled	Siemens Medical Solutions USA	Packaging Defects	Nationwide
6 Sep 2017	CLASS II	Artis zee/zeego and Artis Q/Q.zen system, x-ray recalled	Siemens Medical Solutions USA	Packaging Defects	Nationwide
6 Sep 2017	CLASS II	Artis zee/zeego and Artis Q/Q.zen system, x-ray recalled	Siemens Medical Solutions USA	Packaging Defects	Nationwide
6 Sep 2017	CLASS II	Artis zee/zeego and Artis Q/Q.zen system, x-ray recalled	Siemens Medical Solutions USA	Packaging Defects	Nationwide
6 Sep 2017	CLASS II	Artis zee/zeego and Artis Q/Q.zen system, x-ray recalled	Siemens Medical Solutions USA	Packaging Defects	Nationwide
6 Sep 2017	CLASS II	Artis zee/zeego and Artis Q/Q.zen system, x-ray recalled	Siemens Medical Solutions USA	Packaging Defects	Nationwide
6 Sep 2017	CLASS II	Artis zee/zeego and Artis Q/Q.zen system, x-ray recalled	Siemens Medical Solutions USA	Packaging Defects	Nationwide
6 Sep 2017	CLASS II	Artis zee/zeego and Artis Q/Q.zen system, x-ray recalled	Siemens Medical Solutions USA	Packaging Defects	Nationwide
6 Sep 2017	CLASS II	Artis zee/zeego and Artis Q/Q.zen system, x-ray recalled	Siemens Medical Solutions USA	Packaging Defects	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

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	Packaging Defects	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 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 Nederl	Potency & Assay