Z-0978-2022 Class II Ongoing
FDA device recall Z-0978-2022 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: 33 systems.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 27, 2022
- Initiation Date
- Feb 23, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 33 systems
Product Description
Artis Q.zen floor, Model Number 10848353
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: 4056869010014; Serial Numbers: 105120 105110 105033 105032 105500 105105 105028 105503 105018 105114 105115 105026 105025 105135 105016 105119 105137 105501 105132 105128 105142 105017 105121 105122 105123 105100 105112 105124 105029 105030 105031 105125 Additional Serial Numbers as of 10/4/23: 143500
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0978-2022
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026