Z-0971-2022 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- April 27, 2022
- Initiation Date
- February 23, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 24 systems
Product Description
Artis zee floor MN, Model Number 10094142
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 Pattern
US Nationwide.
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