FDA Device recall Z-1645-2022
Artis Q floor- Model No. 10848280 Artis Q ceiling- Model No. 10848281 Artis Q biplane- Model No. 10848282 Artis Q zeego- Model No. 10848283…
- FDA Device
- Class II
- ongoing
- Published 2022-09-07
On 2022-09-07 the FDA classified a Class II recall of Artis Q floor- Model No. 10848280 Artis Q ceiling- Model No. 10848281 Artis Q biplane- Model No. 10848282 Artis Q zeego- Model No. 10848283… by Siemens Medical Solutions Usa, citing siemens has become aware of a potential hardware issue with Artis Q, Artis Q.zen, Artis pheno and Artis icono systems with a specific lot of X-ray tubes. In rare cases, if the err….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1645-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-08-10 |
| Published | 2022-09-07 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
Product
Artis Q floor- Model No. 10848280 Artis Q ceiling- Model No. 10848281 Artis Q biplane- Model No. 10848282 Artis Q zeego- Model No. 10848283 Artis Q.zen floor- Model No. 10848353 Artis Q.zen ceiling- Model No. 10848354 Artis Q.zen biplane- Model No. 10848355
Reason
Siemens has become aware of a potential hardware issue with Artis Q, Artis Q.zen, Artis pheno and Artis icono systems with a specific lot of X-ray tubes. In rare cases, if the error detection mechanism fails, it will not be possible to release X-ray any longer until system shutdown.
Identifiers
| code_info | Artis Q floor- Model No. 10848280 UDI-DI: 4056869009971 Serial Numbers 103221 103217 104049 103409 103232 104005 1040…Artis Q floor- Model No. 10848280 UDI-DI: 4056869009971 Serial Numbers 103221 103217 104049 103409 103232 104005 104027 132508 132510 103359 104051 103220 104029 103365 104025 103286 103222 132507 104047 132502 132509 132500 103241 103212 103254 103255 ***Updated 9/23/22*** 103035 ***Updated 1/9/23*** 103444 103050 Artis Q ceiling- Model No. 10848281 UDI-DI: 4056869009988 Serial Numbers 109552 110088 110199 110059 110103 133503 110166 109123 110005 109344 109628 110058 110156 110176 110180 110147 110181 110056 110158 109074 109479 109197 109421 109792 109738 109405 110195 109437 109645 109166 110067 110161 110184 110169 110119 109747 110144 109760 110095 110167 110192 110131 109169 110093 109769 133202 109202 110109 110128 109378 109384 110096 109621 133504 110198 109015 110069 110106 110139 109211 109726 110185 110075 109674 109627 109780 110179 110063 110047 110102 109656 109309 110023 110110 110159 110065 110052 109057 109915 110191 109604 110136 110201 109457 110072 109034 109 |
|---|
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-1645-2022%22
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