Z-0977-2022 Class II Ongoing
FDA device recall Z-0977-2022 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: 38 systems.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 27, 2022
- Initiation Date
- Feb 23, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 38 systems
Product Description
Artis Q zeego, Model Number 10848283
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: 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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0977-2022
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026