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Recall Observatory FDA recall evidence

Device product

Artis Q zeego, Model Number 10848283

Z-0977-2022

February 23, 2022

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
Event
Event 89860
Status
Ongoing
Classification
Class II
Quantity
38 systems
Official record key
device-enforcement:Z-0977-2022

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: 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

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".