CLASS II Device recall · Reported 7 Mar 2018 · FDA Enforcement Report

Axiom Artis recalled by Siemens Medical Solutions USA

Siemens Medical Solutions USA is recalling Axiom Artis, distributed nationwide in the US. The recall was initiated on 6 Jun 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes10094135, 10094137, 10094141, 10094142, 10094143, 10280959, 10848280, 10848281, 10848282, 10848353, 10848354, 10848355, 5904433, 5904441, 5904649, 5904656, 5917054, 7007755, 7008605, 7412807, 7413078, 7555357, 7555373, 7727717, 7728350, 7728392

Quantity recalledN/A

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-0708-2018
FDA event ID: 79097
Recalling firm: Siemens Medical Solutions USA, Malvern, PA
Classification: Class II
Status: Terminated
Recall initiated: 6 Jun 2017
FDA classified: 23 Feb 2018
Reported: 7 Mar 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

6 Jun 2017	Recall initiated by company
23 Feb 2018	Classified by FDA	+262 days
7 Mar 2018	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

Potential for liquid entry

Product as listed by the FDA

Axiom Artis, Model Numbers: 5904433, 5904441, 5904649, 5904656, 5917054, 7007755, 7008605, 7412807, 7413078, 7555357, 7555373, 7727717, 7728350 & 7728392

Where it was distributed

U.S. Nationwide

Nationwide

Questions about this recall

Is Axiom Artis recalled?

Yes. Siemens Medical Solutions USA recalled Axiom Artis on 6 Jun 2017. The recall is Class II and its status is Terminated. Recall number Z-0708-2018.

Why was it recalled?

Potential for liquid entry

Which lots are affected?

10094135, 10094137, 10094141, 10094142, 10094143, 10280959, 10848280, 10848281, 10848282, 10848353, 10848354, 10848355, 5904433, 5904441, 5904649, 5904656, 5917054, 7007755, 7008605, 7412807, 7413078, 7555357, 7555373, 7727717, 7728350, 7728392

Where was it sold?

U.S. 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 Other Medical Devices recalls

All 13,771

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Medline Convenience Kits: Blood Draw Kit recalled by Medline Industries	Medline Industries	Sterility	Nationwide
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: Ortho Aspiration Kit recalled	Medline Industries	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits containing BD ChloraPrep DYKA1054F recalled	Medline Industries	Lead & Heavy Metals	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits: Arterial Line Insertion Kit recalled	Medline Industries	Sterility	Nationwide