FDA Device recall Z-0975-2022
Artis Q ceiling, Model Number 10848281
- FDA Device
- Class II
- ongoing
- Published 2022-04-27
On 2022-04-27 the FDA classified a Class II recall of Artis Q ceiling, Model Number 10848281 by Siemens Medical Solutions Usa, citing if the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system wil….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0975-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-02-23 |
| Published | 2022-04-27 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
Product
Artis Q ceiling, Model Number 10848281
Reason
If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display the message "TUBE HOT, have a break". Several minutes later the system will block X-ray to prevent further damage and display the message "NO XRAY: TUBE TOO HOT".
Identifiers
| code_info | UDI: 4056869009988; Serial Numbers: 109130 109490 109552 110088 110059 110103 133503 109799 110035 109642 109892 109135…UDI: 4056869009988; Serial Numbers: 109130 109490 109552 110088 110059 110103 133503 109799 110035 109642 109892 109135 109569 109123 110046 109400 110005 109812 109727 109210 109628 110058 109931 110056 109080 109610 110062 109074 109746 109417 109479 109352 109388 109190 109191 109197 109198 109418 109419 109421 133000 133201 109305 109789 109792 109889 109592 109738 109405 109657 109119 109346 109016 109523 109645 109118 109693 109493 110067 109583 109817 109460 109137 109512 109155 109379 109681 109820 109709 110119 109187 109663 109787 109747 109228 109327 109412 109066 109067 109068 109760 110095 109084 109133 109134 110051 109833 109365 109217 109366 110001 110020 109688 109203 109367 110007 109169 109434 109589 109838 110093 109769 109660 109651 133202 110109 110128 109378 109384 109639 109598 109893 109783 110096 109621 109653 109500 109602 109748 109451 109504 109505 109143 109526 109565 109102 109431 109383 109785 109794 109407 109015 109029 109136 109442 110069 110106 10919 |
|---|
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-0975-2022%22
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