FDA Device recall Z-2342-2015
Axiom Artis systems, dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures includ…
- FDA Device
- Class II
- terminated
- Published 2015-08-12
On 2015-08-12 the FDA classified a Class II recall of Axiom Artis systems, dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures includ… by Siemens Medical Solutions Usa, citing the possibility exists for a large amount of liquid to seep through the top cover of the table and penetrate the components inside the table. If this occurs, table movements may n….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2342-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-06-29 |
| Published | 2015-08-12 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
Product
Axiom Artis systems, 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
The possibility exists for a large amount of liquid to seep through the top cover of the table and penetrate the components inside the table. If this occurs, table movements may no longer be possible. No injuries reported.
Identifiers
| code_info | Model Number of device: 7727717 7555357 7728392 5917054 7555373 7412807 7008605 7413078 7007755 7728350 59046…Model Number of device: 7727717 7555357 7728392 5917054 7555373 7412807 7008605 7413078 7007755 7728350 5904649 5904433 5904656 5904441 serial numbers: 28151 14101 35143 35239 37701 46017 46022 46023 53181 40023 55163 55057 28100 40072 44151 53104 53067 28021 40075 32099 32101 35456 10373 10407 10326 14095 46154 46107 55157 28108 44101 35327 53093 25209 35368 44246 46071 46072 25267 50063 35432 35690 44185 55304 10328 28119 53162 30002 35301 35451 35553 46263 25280 25163 55399 35427 35743 35750 35762 40012 46079 44262 53201 55435 55567 35778 35788 50059 10255 28070 35020 10235 10017 10142 25004 46134 46274 55407 55412 55310 25090 40000 10355 28117 28145 10366 10432 55395 35736 10338 25101 14111 53706 40015 35350 35369 55129 35158 25069 55120 55470 28144 50006 49006 35297 50187 50064 44263 10012 55164 55187 35019 35601 53098 35438 55091 46087 53066 44046 5 |
|---|
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-2342-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.