Z-0218-2026 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- October 29, 2025
- Initiation Date
- September 12, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 22 units
Product Description
Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 550 MD, Rx Only
Reason for Recall
Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.
Distribution Pattern
US: OUS:
Code Information
UDI:(01)06971576831036/ Serial Numbers: 353020 353021 353023 353045 353049 354001 354002 354003 354004 354005 354006 354007 354008 354009 354010 354011 354012 354013 354014 354015 354016 354017