CLASS II Device recall · Reported 6 Apr 2016 · FDA Enforcement Report

Axiom Artis (system, x-ray, angiographic) for single recalled

Siemens Medical Solutions USA is recalling Axiom Artis (system, x-ray, angiographic) for single and biplane diagnostic imaging and, distributed nationwide in the US. The recall was initiated on 19 Feb 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel Numbers: 5917054, 7008605, 7412807, 7413078, 7555357, 7555365, 7555373, 7727717, 7728392, 10094135, 10094137, 10094139, 10094141, 10094142, 10094143, 10280959

Quantity recalled1757 angiography systems

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-1310-2016
FDA event ID: 73589
Recalling firm: Siemens Medical Solutions USA, Malvern, PA
Classification: Class II
Status: Terminated
Recall initiated: 19 Feb 2016
FDA classified: 31 Mar 2016
Reported: 6 Apr 2016
Type: Voluntary: Firm initiated
Customers notified by: N/A
Reason category: Packaging Defects
Device type: Imaging Equipment

Timeline

19 Feb 2016	Recall initiated by company
31 Mar 2016	Classified by FDA	+41 days
6 Apr 2016	Published in enforcement report	+6 days

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

Reason for recall

Possible leak in the cooling system, fluids could potentially seep into the equipment cabinet. This leak 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

AXIOM Artis (system, x-ray, angiographic) for single and biplane diagnostic imaging and interventional procedures such as cardiac and neuro angiography, general and rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.

Where it was distributed

Nationwide distribution: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and Puerto Rico

Nationwide Alaska Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Delaware Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts

Questions about this recall

Is Axiom Artis (system, x-ray, angiographic) for single and biplane diagnostic imaging and recalled?

Yes. Siemens Medical Solutions USA recalled Axiom Artis (system, x-ray, angiographic) for single and biplane diagnostic imaging and on 19 Feb 2016. The recall is Class II and its status is Terminated. Recall number Z-1310-2016.

Why was it recalled?

Possible leak in the cooling system, fluids could potentially seep into the equipment cabinet. This leak can occur sporadically in affected systems.

Which lots are affected?

Model Numbers: 5917054, 7008605, 7412807, 7413078, 7555357, 7555365, 7555373, 7727717, 7728392, 10094135, 10094137, 10094139, 10094141, 10094142, 10094143, 10280959

Where was it sold?

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.

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