Z-0971-2022 Class II Ongoing
FDA device recall Z-0971-2022 was initiated by Siemens Medical Solutions USA, Inc on Feb 23, 2022 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 24 systems.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 27, 2022
- Initiation Date
- Feb 23, 2022
- 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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0971-2022
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026