Artis Q floor, Model Number 10848280
Check against the official notice below — it lists the full affected range.
Siemens Medical Solutions USA, Inc. is recalling 80 Artis Q floor X-ray systems (Model Number 10848280) distributed nationwide due to a coolant circuit hazard. If the coolant level in the cooling circuit drops below a certain level, the X-ray tube may not be sufficiently cooled. When this occurs, the system will first display "TUBE HOT, have a break," and several minutes later will block X-ray functionality and display "NO XRAY: TUBE TOO HOT" to prevent further equipment damage.
The recall affects systems with specific serial numbers listed in the FDA record. The source does not specify a remedy for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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".
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: 80 systems Lot/code info: UDI: 4056869009971; Serial Numbers: 103221 103217 103218 103345 103409 103340 103439 104007 103302 103232 104016 104005 103391 103404 104027 132002 103334 103354 103359 103030 103335 104012 103220 103013 103384 103035 104029 104020 103039 103050 103365 103279 104025 103285 103286 103207 103222 103230 103295 103310 103430 103432 104047 103001 103239 103353 104013 103444 132502 132500 103048 103315 103263 103356 132000 103028 103241 103293 103388 103389 132003 103245 103348 103253 Additional Serial Numbers as of 10/4/23: 160501 160519 160406 160900 160850 160959 160461 103053 103040 160903 126206 160905 160930 160967 160925 160469
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.