FDA Device recall Z-2404-2015
Artis zee/ zeego systems
- FDA Device
- Class II
- terminated
- Published 2015-08-26
On 2015-08-26 the FDA classified a Class II recall of Artis zee/ zeego systems by Siemens Medical Solutions Usa, citing in case a system error occurs and the system enters the "Bypass Fluoro" mode while the X-ray locking function is active, the only way to exit the X-ray locking function, would be….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2404-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-06-30 |
| Published | 2015-08-26 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
Product
Artis zee/ zeego systems; dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
Reason
in case a system error occurs and the system enters the "Bypass Fluoro" mode while the X-ray locking function is active, the only way to exit the X-ray locking function, would be to either resolve the root cause of the system being in "Bypass Fluoro" or to restart the system.
Identifiers
| code_info | Model Numbers of device: 10094135, 10094137, 10094139, 10094141, 10094142, 10094143, 10280959 with serial numbers: 1466…Model Numbers of device: 10094135, 10094137, 10094139, 10094141, 10094142, 10094143, 10280959 with serial numbers: 146669 153131 153229 146877 157435 146663 147100 147049 147233 136077 147189 147190 153695 157660 153727 157458 146335 146659 153779 146993 153280 153648 153674 160395 160484 135757 136513 136562 147273 157698 147030 147239 146988 160348 157532 160502 146899 135102 153169 146643 136042 153803 146361 146365 146366 146369 146116 146164 146168 153110 160392 147371 160115 135986 157690 154074 154012 147129 135841 153732 147210 160449 153274 157710 160463 146235 147267 153227 154090 153655 157677 153234 153285 157528 146741 147047 157503 154095 153328 146195 146113 146187 146189 146636 147042 157615 153106 153916 160134 160136 146630 146766 146154 146298 154086 135235 147208 147247 147096 160347 147236 140101 140205 147175 157700 153139 160506 136568 153211 147023 14685 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2404-2015%22
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