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

Siemens Medical Solutions USA, Inc: Artis zee floor, Model Number 10094135

Is my product affected?

Artis zee floor, Model Number 10094135

  • UPC 4056869010045

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

What happened

Siemens Medical Solutions USA, Inc. is recalling 305 Artis zee floor X-ray systems (Model Number 10094135) distributed nationwide. The systems may experience insufficient cooling of the X-ray tube if the coolant level in the cooling circuit drops below a certain level. 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 can be identified by UDI 4056869010045 and specific serial numbers listed in the recall documentation. The source document does not specify a remedy or corrective action that affected consumers should take.

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: 305 systems Lot/code info: UDI: 4056869010045; Serial Numbers: 138481 137729 124071 138390 135944 137623 135111 135112 124267 124253 137165 124335 124338 124400 137391 137714 124081 135120 137282 135358 137618 137226 135757 136513 137103 137118 137461 135102 136042 138124 138132 135927 137510 138260 138012 138058 137193 135986 135935 135953 138055 124303 135841 138497 135200 135201 135279 124061 135879 135229 136113 135990 138035 138214 137479 138156 124083 137532 137540 136077 124102 137314 135862 124116 135235 135117 135920 137295 136168 138087 137582 137592 138221 138112 135366 138084 137075 124115 135843 138057 138118 138061 135779 136224 124395 137130 137188 137131 137146 137662 135137 138071 138102 138486 136579 137388 137470 124007 137011 136280 138311 136286 137347 135109 137766 124384 138128 137638 137731 124383 138017 124394 137595 135144 135145 136362 138259 137245 137620 137335 137607 137617 136318 136234 138402 135151 135421 135760 136500 135217 137369 136031 136032 137421 135124 136084 137569 136026 137425 136479 135285 136338 136196 135245 135420 124051 136384 136387 136488 136256 135767 136408 136508 135182 137650 137668 136242 136383 135788 136517 135406 136043 137311 137320 137360 138163 135129 135416 138004 135222 136393 124268 137639 135302 135260 137736 138194 124273 138325 138358 135143 137645 135114 137093 136350 138193 135253 135772 138201 138250 135190 124378 137591 137438 135881 136614 136567 138104 135714 137656 138119 124302 138147 137239 138005 136089 138367 138397 135180 1

Source

Official record: FDA (Device enforcement) ↗

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

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