FDA Device recall Z-3189-2018
Artis Q Interventional Fluoroscopic X-Ray System, Model Numbers 10848280, 10848281, 10848282, 10848283, 10848354 & 10848355
- FDA Device
- Class II
- terminated
- Published 2018-09-26
On 2018-09-26 the FDA classified a Class II recall of Artis Q Interventional Fluoroscopic X-Ray System, Model Numbers 10848280, 10848281, 10848282, 10848283, 10848354 & 10848355 by Siemens Medical Solutions Usa, citing temperature of the detector may fall out of its designed working range (cool down) due to incorrectly configured temperature control unit. This unintentional system behavior may o….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3189-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-07-29 |
| Published | 2018-09-26 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
Product
Artis Q Interventional Fluoroscopic X-Ray System, Model Numbers 10848280, 10848281, 10848282, 10848283, 10848354 & 10848355
Reason
Temperature of the detector may fall out of its designed working range (cool down) due to incorrectly configured temperature control unit. This unintentional system behavior may occur while the unit is powered down for long periods (e.g. at night).
Identifiers
| code_info | 103221 103061 103217 103030 103218 103220 103013 103053 103039 103050 103008 103207 103222 103035 103001…103221 103061 103217 103030 103218 103220 103013 103053 103039 103050 103008 103207 103222 103035 103001 103048 103028 103212 103040 109033 109135 109141 109123 109344 109210 109080 109074 109352 109388 109190 109191 109197 109198 109305 109119 109346 109016 109118 109166 109137 109155 109379 109300 109187 109228 109327 109066 109067 109068 109084 109133 109134 109365 109217 109366 109203 109011 109367 109169 109096 109159 109358 109202 109130 109378 109384 109143 109102 109383 109015 109211 109144 109332 109309 109304 109168 109227 109057 109221 109162 109108 109103 109165 109038 109040 109324 109183 109034 109129 109181 109029 109136 109064 109009 109194 109132 109226 109219 109321 109330 109058 109145 109050 109380 109222 109224 109225 109076 109386 109179 109007 109188 109229 109357 109071 109072 109075 109231 109355 109091 109393 109090 109311 109041 109164 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3189-2018%22
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