Z-0972-2022 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
- 7 systems
Product Description
Artis zee biplane MN, Model Number 10094143
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: 4056869010106; Serial Numbers: 149100 149401 149421 149106 149202 149420 149402