Z-1310-2016Class II

AXIOM Artis (system, x-ray, angiographic) for single and biplane diagnostic imaging and interventional...

Name: Z-1310-2016 AXIOM Artis (system, x-ray, angiographic) for single and biplane diagnostic imaging and interventional...
Creator: Siemens Medical Solutions USA, Inc
Published: 2016-02-19
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2016-02-19 / Terminated

FDA source

Siemens Medical Solutions USA, Inc began a recall of AXIOM Artis (system, x-ray, angiographic) for single and biplane diagnostic imaging and interventional procedures such as cardiac and neuro angiography... on 2016-02-19. FDA classified it as Class II and gives the reason as "Possible leak in the cooling system, fluids could potentially seep into the equipment cabinet. This leak can occur sporadically in affected systems". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1310-2016
Classification: Class II
Status: Terminated
Initiated: 2016-02-19
Posted: 2016-03-31
Terminated: 2018-05-10
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: 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.
Product code: JAA System, X-Ray, Fluoroscopic, Image-Intensified
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.
FDA root cause: Other
Action: Siemens mailed out an Important Customer Safety Notice to customers informing them of a corrective action that will be performed to prevent a possible leak in the detector cooling system of Axiom Artis and Artis zee systems. The notice stated the affected plastic couplings will be replaced with metal couplings to prevent fluid leaks. Siemen's service organization will contact each customer to arrange a date to perform the corrective action. Customers asked to call 1-800-888-7436 to schedule an appointment for the corrective action to be implemented.
Quantity in commerce: 1757 angiography systems
Distribution: 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
Product codes and lots: Model Numbers: 5917054, 7008605, 7412807, 7413078, 7555357, 7555365, 7555373, 7727717, 7728392, 10094135, 10094137, 10094139, 10094141, 10094142, 10094143, 10280959

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1310-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1310-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-06	2016-03-31
Z-1311-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-06	2016-03-31

Product code JAA

K021021Class IIModular Angiography System Axiom ArtisSiemens Medical Solutions USA, Inc. / cleared 2002-06-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)