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FDA (Device enforcement)Recalled 2022-02-23class ii

Siemens Medical Solutions USA, Inc: Artis zee ceiling, Model Number 10094137

Is my product affected?

Artis zee ceiling, Model Number 10094137

  • UPC 4056869010052

Check against the official notice below — it lists the full affected range.

What happened

Siemens Medical Solutions USA, Inc. is recalling 709 Artis zee ceiling X-ray systems (Model Number 10094137) distributed nationwide. If the coolant level in the cooling circuit drops below a certain threshold, the X-ray tube may not be sufficiently cooled. When this occurs, the system displays a "TUBE HOT, have a break" message, and several minutes later blocks X-ray functionality and displays "NO XRAY: TUBE TOO HOT" to prevent further equipment damage.

The affected systems have specific serial numbers listed in the recall record. The source document does not specify what action an affected consumer should take in response to this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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".

Details from the source

Reason for recall: 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". Distribution: US Nationwide. Quantity: 709 systems Lot/code info: UDI: 4056869010052; Serial Numbers: 146669 146877 146996 146663 147100 146286 146292 146410 146676 148281 148299 147155 147678 146406 146407 146411 146166 147762 146121 147885 146710 125115 125276 125262 146945 125253 125213 125238 125245 147189 147190 146679 150011 146766 148429 125265 146232 147573 148454 147996 146408 146409 146728 148498 147889 146335 148404 146659 148499 148235 147909 147833 147847 147888 146898 148402 148333 150002 147273 125105 125106 147761 146814 146871 147783 147891 147581 147857 147882 146899 146368 146643 125100 147608 147983 146650 146361 146365 146366 146369 146912 146116 146164 146168 150017 147604 147079 125216 125202 125209 147371 146156 146343 148401 148486 148487 148488 148485 147899 147129 146260 146277 125013 147760 147923 147636 147081 146235 148423 146868 148422 148509 146758 146818 146741 146174 125255 147507 147047 147667 147679 148348 147685 125011 125111 147803 146173 146176 146186 146187 146189 146630 147630 146266 125249 125281 125286 125278 146305 146908 125241 148349 148384 146267 146219 146272 146274 147096 125022 147912 148260 148335 148390 146298 147982 146637 125268 147841 147078 146327 146333 146338 147786 148465 147924 147023 148220 125211 147910 148288 147919 147921 125021 148463 148490 146851 147514 147954 146688 147918 148393 148513 146144 148250 125256 147188 146324 147925 147926 147928 147558 146715 146293 125267 125269 146308 147105 147955 147956 147957 147958 148001 146825 146827 146828 147304 148277 146937 147024 1

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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