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

Siemens Medical Solutions USA, Inc: Artis Q zeego, Model Number 10848283

Is my product affected?

Artis Q zeego, Model Number 10848283

  • UPC 4056869010007

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

What happened

Siemens Medical Solutions USA, Inc. is recalling 38 Artis Q zeego X-ray systems (Model Number 10848283) distributed nationwide. The systems may experience a cooling circuit malfunction where coolant levels drop below safe operating levels, preventing the X-ray tube from cooling properly. 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 equipment damage.

The affected systems have specific serial numbers ranging from 117001 to 117329. The source document does not specify a remedy or recommended action for consumers who may have an affected unit.

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: 38 systems Lot/code info: UDI: 4056869010007; Serial Numbers: 117021 117136 117324 117108 117001 117023 117329 117315 117125 117006 117312 117124 117129 117112 117034 117026 117029 117123 117100 117307 117117 117111 117304 117024 117325 117303 117030 117314 117309 117113 117322 117014 117040 117041 117114 117009 Additional Serial Numbers as of 10/4/23: 117127 117310

Source

Official record: FDA (Device enforcement) ↗

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

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