FDA Device recall Z-2028-2019
Artis zee floor, Model Number 10094135
- FDA Device
- Class II
- terminated
- Published 2019-07-31
On 2019-07-31 the FDA classified a Class II recall of Artis zee floor, Model Number 10094135 by Siemens Medical Solutions Usa, citing A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the r….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2028-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-06-12 |
| Published | 2019-07-31 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
Product
Artis zee floor, Model Number 10094135
Reason
A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue occurs sporadically; however, it may occur during an on-going procedure.
Identifiers
| code_info | Serial Numbers: 135944 135746 135120 135322 135757 136513 136562 135914 135102 136042 135927 135986 135935…Serial Numbers: 135944 135746 135120 135322 135757 136513 136562 135914 135102 136042 135927 135986 135935 135953 135841 135200 135201 135279 135169 135879 135229 135157 136113 135990 136077 136103 135862 135235 135117 135358 135920 136168 135148 135366 136568 135843 135111 135112 135779 136224 135137 136607 136579 135309 124007 124015 136280 136286 135109 135413 135144 135145 136362 135404 136318 136234 135151 135421 135264 135199 135760 136500 136515 135217 136031 136032 135124 135125 136084 136026 136479 135179 135394 135285 136338 136196 135245 135420 136384 136387 136488 135770 136550 136256 136408 136450 136508 136547 135788 136242 136383 136517 135406 136043 136586 135129 135416 135909 135222 136393 136520 135258 135260 135755 136548 135143 135114 135133 136350 135353 135253 135375 135772 136483 136555 135190 135881 136614 137384 136567 135714 135922 136314 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2028-2019%22
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