FDA Device recall Z-1040-2023
System Material # Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee multi-purpose 10094139 Artis zee biplane 10094141 Artis zee…
- FDA Device
- Class II
- ongoing
- Published 2023-02-08
On 2023-02-08 the FDA classified a Class II recall of System Material # Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee multi-purpose 10094139 Artis zee biplane 10094141 Artis zee… by Siemens Medical Solutions Usa, citing in rare cases, the system may only boot into backup mode after an abrupt shutdown and not reach full operating mode. This may result in a situation where it is necessary to cancel….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1040-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-12-16 |
| Published | 2023-02-08 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
Product
System Material # Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee multi-purpose 10094139 Artis zee biplane 10094141 Artis zeego 10280959 Artis Q floor 10848280 Artis Q ceiling 10848281 Artis Q biplane 10848282 Artis Q.zeego 10848283 Artis Q.zen floor 10848353 Artis Q.zen ceiling 10848354 Artis Q.zen biplane 10848355 Fluoroscopic X-Ray System
Reason
In rare cases, the system may only boot into backup mode after an abrupt shutdown and not reach full operating mode. This may result in a situation where it is necessary to cancel clinical treatment or to continue treatment on an alternative system.
Identifiers
| code_info | Artis zee floor UDI-DI 4056869010045 Serial Numbers 138481 124714 138390 138497 124709 124395 138102 138071 124383 124…Artis zee floor UDI-DI 4056869010045 Serial Numbers 138481 124714 138390 138497 124709 124395 138102 138071 124383 124706 137617 137607 139133 137752 137736 138325 138358 139120 124378 124713 139127 138397 138367 124703 138070 124388 124708 139012 139023 124724 138340 138051 Artis zee ceiling UDI-DI 4056869010052 Serial numbers 150011 150062 148498 150060 150002 147983 150017 148486 148487 148488 125716 148260 148288 147954 125267 125269 147956 147958 147957 147955 148001 148277 125700 147974 150040 125705 147969 148270 150036 150005 148019 147120 147119 148361 150023 148479 147114 125257 125119 148431 148474 150009 150015 148029 147952 148484 148466 148489 125715 150003 150046 150047 125254 148240 148239 Artis zee multi-purpose UDI-DI 4056869010076 Serial numbers 159088 159190 158650 158652 158742 159124 130241 159157 159030 159085 159117 130714 159034 158225 159156 159038 159181 159032 159046 158183 159175 158272 159054 159099 158519 159177 158495 159015 159127 159058 159028 15 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1040-2023%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.