FDA Device recall Z-3089-2017
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-3089-2017 |
| 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 Q.zen biplane- Serial number: 123026 123031 123008 123035 123003 123011 123032 123013 123014 123025 123…Artis Q.zen biplane- Serial number: 123026 123031 123008 123035 123003 123011 123032 123013 123014 123025 123036 123022 123024 123023 123027 123037 123043 123010 123016 123015 |
|---|
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-3089-2017%22
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