Z-1283-2016Class II

AXIOM Artis zee/zeego, system, x-ray, angiographic

Name: Z-1283-2016 AXIOM Artis zee/zeego, system, x-ray, angiographic
Creator: Siemens Medical Solutions USA, Inc
Published: 2016-02-18
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2016-02-18 / Terminated

FDA source

Siemens Medical Solutions USA, Inc began a recall of AXIOM Artis zee/zeego, system, x-ray, angiographic Product Usage: AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed for single... on 2016-02-18. FDA classified it as Class II and gives the reason as "Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. Loss of coolant can result in a cooling system failure and subsequent system failure. This leak can occur sporadically in...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1283-2016
Classification: Class II
Status: Terminated
Initiated: 2016-02-18
Posted: 2016-03-31
Terminated: 2017-08-08
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: AXIOM Artis zee/zeego, system, x-ray, angiographic Product Usage: 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.
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. Loss of coolant can result in a cooling system failure and subsequent system failure. This leak can occur sporadically in affected systems.
FDA root cause: Unknown/Undetermined by firm
Action: Siemens sent an Important Customer Safety Notice to customers on February 18, 2016 informing them that their service organization will contact them to arrange a date to perform the corrective action (replacement of affected plastic couplings with metal couplings to prevent fluid leaks). Customers were advised to contact Siemens service organization for an earlier appointment at 1-800-888-7436.
Quantity in commerce: 986 systems in total
Distribution: US Nationwide Distribution in the states of: AL, AR, AZ, CA, CO, CT, DC, FL, GA, GU, 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, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY including Puerto Rico.
Product codes and lots: Serial Numbers: Artis Q biplane Serial # 121061, 121089, 121094, 121006, 121013, 121040, 121062, 121082, 121011, 121039, 121134, 121053, 121054, 121014, 121112, 121051, 121004, 121133, 121018, 121036, 121137, 121012, 121049, 121078, 121019, 121010, 121139, 121081, 121096, 121015, 121115, 121016, 121138, 121020, 121140, 121106, 121120, 121122, 121121, 121109, 121144, 121047, 121088, 121027, 121136, 121141, 121069, 121009, 121057, 121056, 121034, 121008, 121058, 121085, 121071, 121023, 121079, 121041, 121037, 121046, 121072

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1283-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1283-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-06	2016-03-31
Z-1284-2016	Class II	Terminated	Voluntary: Firm initiated	2016-04-06	2016-03-31

Product code OWB

K123529Class IIArtis Q and Q.zen- Modular Angiographic SystemSiemens Medical Solutions USA, Inc. / cleared 2013-02-26

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)