FDA Device recall Z-1283-2016
AXIOM Artis zee/zeego, system, x-ray, angiographic Product Usage: AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems…
- FDA Device
- Class II
- terminated
- Published 2016-04-06
On 2016-04-06 the FDA classified a Class II 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… by Siemens Medical Solutions Usa, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1283-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-02-18 |
| Published | 2016-04-06 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
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.
Reason
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.
Identifiers
| code_info | Serial Numbers: Artis Q biplane Serial # 121061, 121089, 121094, 121006, 121013, 121040, 121062, 121082, 121011, 12…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1283-2016%22
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