Exact FDA event identifier

Event 73672

2 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: February 18, 2016
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Siemens Medical Solutions USA, Inc

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

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.

Z-1283-2016

Recall number: Z-1283-2016
Initiated: February 18, 2016
Classification: Class II
Status: Terminated
Recalling firm: Siemens Medical Solutions USA, Inc
Quantity: 986 systems in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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

Distribution pattern

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.

device · product 2 of 2

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.

Z-1284-2016

Recall number: Z-1284-2016
Initiated: February 18, 2016
Classification: Class II
Status: Terminated
Recalling firm: Siemens Medical Solutions USA, Inc
Quantity: 986 systems in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Code information

Serial Numbers: Artis Q Ceiling 109033, 109135, 109141, 109123, 109080, 109074, 109119, 109016, 109118, 109155, 109067, 109066, 109068, 109134, 109133, 109084, 109011, 109096, 109159, 109130, 109143, 109102, 109015, 109144, 109009, 109057, 109108, 109103, 109038, 109040, 109034, 109129, 109137, 109029, 109136, 109064, 109132, 109058, 109145, 109050, 109076, 109007, 109072, 109075, 109071, 109091, 109090, 109041, 109039, 109060, 109146, 109088, 109092, 109032, 109021, 109048, 109020, 109036, 109043, 109161, 109101, 109105, 109104, 109107, 109047, 109031, 109028, 109027, 109120, 109010, 109093, 109157, 109156, 109069, 109158, 109044