FDA Device recall Z-0976-2022
Artis Q biplane, Model Number 10848282
- FDA Device
- Class II
- ongoing
- Published 2022-04-27
On 2022-04-27 the FDA classified a Class II recall of Artis Q biplane, Model Number 10848282 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-0976-2022 |
| 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 biplane, Model Number 10848282
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: 4056869009995; Serial Numbers: 134007 121314 134008 121396 121590 121665 121564 122025 121627 121185 121430 121406…UDI: 4056869009995; Serial Numbers: 134007 121314 134008 121396 121590 121665 121564 122025 121627 121185 121430 121406 121336 122012 121471 121195 121467 121612 122022 121530 121089 121094 134004 121169 121006 122021 122028 121013 121040 121501 121368 121526 121208 121548 121515 121445 121446 121623 121082 121459 121011 122037 121039 121521 121371 122005 121374 121204 121614 121305 121536 121053 121054 121422 121014 121112 121325 121357 121621 121167 121378 121369 121604 121133 134011 121200 121490 121163 121364 121642 121018 121154 121418 121605 121547 121365 121205 122034 121137 121324 121012 121049 121078 121096 121332 121333 121344 121183 134003 121455 121504 121019 121491 121381 121457 121460 121352 121563 121635 121434 121165 121625 121415 121355 121010 121171 121139 121210 121573 121215 121542 121366 121323 121370 121493 121556 121391 121384 121015 121487 122017 121395 121472 121558 121405 121309 121513 121342 121301 121081 121551 121633 121649 121190 121315 121629 121529 12113 |
|---|
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-0976-2022%22
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