Artis Q.zen floor, Model Number 10848353
Check against the official notice below — it lists the full affected range.
Siemens Medical Solutions USA, Inc. is recalling 33 Artis Q.zen floor X-ray systems (Model Number 10848353) distributed nationwide. The systems have a defect where the coolant level in the cooling circuit may drop below a safe level, causing the X-ray tube to become insufficiently cooled. When this occurs, the system first displays a message stating "TUBE HOT, have a break," and several minutes later blocks X-ray functionality and displays "NO XRAY: TUBE TOO HOT" to prevent further equipment damage.
The recall affects specific serial numbers including 105120, 105110, 105033, 105032, 105500, 105105, 105028, 105503, 105018, 105114, 105115, 105026, 105025, 105135, 105016, 105119, 105137, 105501, 105132, 105128, 105142, 105017, 105121, 105122, 105123, 105100, 105112, 105124, 105029, 105030, 105031, 105125, and 143500. The recall notice does not specify a remedy or recommended action 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: 33 systems Lot/code info: UDI: 4056869010014; Serial Numbers: 105120 105110 105033 105032 105500 105105 105028 105503 105018 105114 105115 105026 105025 105135 105016 105119 105137 105501 105132 105128 105142 105017 105121 105122 105123 105100 105112 105124 105029 105030 105031 105125 Additional Serial Numbers as of 10/4/23: 143500
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.