FDA Device recall Z-1846-2015
Artis zee/ zeego systems
- FDA Device
- Class II
- terminated
- Published 2015-07-01
On 2015-07-01 the FDA classified a Class II recall of Artis zee/ zeego systems by Siemens Medical Solutions Usa, citing there exists a possible position sensor fault in the swivel base axis not being detected by the system software. When moving, the system could potentially exceed its usual speed,….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1846-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-05-22 |
| Published | 2015-07-01 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
Product
Artis zee/ zeego systems; Product Usage: Usage: Artis zee/ zeego systems are 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 include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. .
Reason
There exists a possible position sensor fault in the swivel base axis not being detected by the system software. When moving, the system could potentially exceed its usual speed, resulting in a collision. No injuries reported.
Identifiers
| code_info | model numbers: 10094135 10094141 10094139 10094142 10094143 with serial numbers: 124002 154502 135746 153172 1…model numbers: 10094135 10094141 10094139 10094142 10094143 with serial numbers: 124002 154502 135746 153172 153315 153317 153318 137165 153992 153335 135120 137282 135322 153101 153102 154616 137226 153166 154536 135000 137103 137118 153700 154096 154454 137461 154715 135914 153834 154789 154779 153194 154532 157449 136085 158108 135927 137510 157136 154157 135209 153199 140106 154721 154722 137193 153887 157988 154571 153269 135935 135953 158091 135200 135201 135279 153191 153252 135169 135879 154612 153717 153239 157560 157509 157436 135990 153889 158132 137425 137479 153967 153236 154658 135229 137532 137540 154686 153273 153251 153254 153344 153342 140115 154567 154480 154093 153197 153171 136103 157448 137314 135862 157165 153831 135117 135358 153256 135920 137295 154704 153154 136168 135148 135939 153882 153311 135366 137075 154727 157977 157602 154408 153987 13 |
|---|
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-1846-2015%22
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