FDA Device recall Z-3094-2017
Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems deve…
- FDA Device
- Class II
- terminated
- Published 2017-09-06
On 2017-09-06 the FDA classified a Class II recall of Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems deve… 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 results in a cooling system failure and subsequent system failur….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3094-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-02-18 |
| Published | 2017-09-06 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
Product
Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic 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 results in a cooling system failure and subsequent system failure. This leek can occur sporadically in affected systems.
Identifiers
| code_info | Artis zee ceiling - Serial number: 146996 147100 147233 147049 147678 147763 147803 147885 147084 147190 1471…Artis zee ceiling - Serial number: 146996 147100 147233 147049 147678 147763 147803 147885 147084 147190 147189 147573 147889 146993 147909 147833 147847 147888 146965 147273 147761 147030 147239 147783 147891 146988 147677 147882 147562 147608 146980 147036 147581 147857 125001 147604 147371 147899 147129 147210 147923 147760 147636 147081 147267 147047 147679 147667 125002 147685 125011 147042 147630 147835 147208 147247 147096 147912 147515 147236 147175 146972 147841 147078 147924 147023 147910 147934 147921 147919 147255 147249 147514 147954 147918 147165 147188 147926 147928 147925 147558 146968 147956 147958 147957 147955 147304 147944 147024 147724 125005 147172 147585 147553 147736 147645 147906 147164 147974 147087 147972 146856 146921 147938 125006 147193 147196 147025 147583 147852 147044 147814 147203 147601 147659 147894 147675 147098 147905 147113 14751 |
|---|
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-3094-2017%22
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