FDA Device recall Z-1339-2019
Artis Zee (material # 10094135, 10094137, 10094141) - Product Usage: AXIOM Artis zee and Q/ Q.zen is a family of dedicated angiography syst…
- FDA Device
- Class II
- terminated
- Published 2019-05-22
On 2019-05-22 the FDA classified a Class II recall of Artis Zee (material # 10094135, 10094137, 10094141) - Product Usage: AXIOM Artis zee and Q/ Q.zen is a family of dedicated angiography syst… by Siemens Medical Solutions Usa, citing in affected Artis systems the movement of the floating tabletop may be blocked after a collision sensor has been activated during system movement.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1339-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-04-09 |
| Published | 2019-05-22 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
Product
Artis Zee (material # 10094135, 10094137, 10094141) - 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 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 and Q/ Q.zen can also support the acquisition of position triggered imaging for spatial data synthesis.
Reason
In affected Artis systems the movement of the floating tabletop may be blocked after a collision sensor has been activated during system movement.
Identifiers
| code_info | Serial Numbers 138260 138221 138259 138250 138268 138266 124286 125245 148402 148401 148384 148390 147249…Serial Numbers 138260 138221 138259 138250 138268 138266 124286 125245 148402 148401 148384 148390 147249 148393 148411 148400 148358 148361 148397 148392 148382 148363 148375 155237 155203 155226 155227 155235 131235 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1339-2019%22
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