FDA Device recall Z-1495-2021
Artis zee ceiling-interventional Fluoroscopic X-Ray System Model Number: 10094137
- FDA Device
- Class II
- ongoing
- Published 2021-05-05
On 2021-05-05 the FDA classified a Class II recall of Artis zee ceiling-interventional Fluoroscopic X-Ray System Model Number: 10094137 by Siemens Medical Solutions Usa, citing some Artis zee ceiling systems show an increased abrasion of the cabling at the cable outlet of the inner C-arm, the limited functionality may not be sufficient to continue with t….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1495-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-03-26 |
| Published | 2021-05-05 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
Product
Artis zee ceiling-interventional Fluoroscopic X-Ray System Model Number: 10094137
Reason
Some Artis zee ceiling systems show an increased abrasion of the cabling at the cable outlet of the inner C-arm, the limited functionality may not be sufficient to continue with treatment as planned. 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 | Serial Numbers: 125000 125001 125002 125003 125004 125005 125006 125008 125009 125010 125011 125013 125015…Serial Numbers: 125000 125001 125002 125003 125004 125005 125006 125008 125009 125010 125011 125013 125015 125016 125017 125019 125021 125022 125023 125024 125100 125105 125106 125108 125109 125112 125113 125115 125116 125117 125118 125119 125201 125202 125204 125205 125208 125209 125210 125211 125212 125213 125214 125216 125219 125222 125223 125226 125227 125228 125229 125230 125231 125232 125233 125235 125238 125239 125240 125241 125243 125244 125245 125249 125250 125251 125253 125254 125255 125256 125257 125260 125262 125263 125265 125267 125268 125269 125270 125273 125274 125275 125276 125278 146104 146107 146111 146116 146118 146119 146121 146123 146130 146136 146137 146138 146139 146140 146144 146147 146149 146150 146152 146156 146158 146161 146164 146166 146168 146169 146170 146173 146174 146175 146176 146178 146179 146181 146183 146184 146186 146187 146188 |
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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-1495-2021%22
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