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Recall Observatory FDA recall evidence

Device product

Artis zee biplane MN, Model Number 10094143

Z-0972-2022

February 23, 2022

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
Event
Event 89860
Status
Ongoing
Classification
Class II
Quantity
7 systems
Official record key
device-enforcement:Z-0972-2022

Official wording

Reason: 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".

Code information: UDI: 4056869010106; Serial Numbers: 149100 149401 149421 149106 149202 149420 149402

Distribution pattern: US Nationwide.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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".