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Recall Observatory FDA recall evidence

Device product

Artis zee floor MN, Model Number 10094142

Z-0971-2022

February 23, 2022

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
Event
Event 89860
Status
Ongoing
Classification
Class II
Quantity
24 systems
Official record key
device-enforcement:Z-0971-2022

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: 4056869010090; Serial Numbers: 140421 140115 140101 140205 140213 140204 140209 140219 140224 140218 140226 140221 140220 140206 140105 140423 140406 140422 140102 140214 140109 140202 140424 140114

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".