Recall Z-0222-2026
UIH Technologies LLC · initiated September 12, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uEXPLORER MD, Rx Only
Codes / lots: UDI: (01)06971576832040; Serial Number: F00002, F00015
Reason for recall
Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.
FDA-determined cause: Other
Action taken
On September 12, 2025, UIH Technologies LLC, issued a recall notification to affected consignees. UIH asked consignees to take the following actions: 1. Ensure patient positioning clearance: When positioning the patient, confirm that arms and legs and clear of all table gaps and moving parts. 2. Avoid use of third-party slickers: We advise against the use of any non-UIH-approved slickers. 3. Service Contact: For technical assistance, contact your United Imaging Service engineer or reach out to our 24/7 Customer Contact Center, Toll-Free: (855) 221-1552/Direct: (832) 699-2799 4.Report adverse events: if any adverse events or quality issue occur, please report them to the FDA via the MedWatch program. 5. Please share this information with all relevant personnel at your facility, including technologist, service staff, and clinical teams.
Details
- Recall number
- Z-0222-2026
- Initiated
- September 12, 2025
- Posted by FDA
- October 21, 2025
- Product code
- JAK – System, X-Ray, Tomography, Computed
- Quantity
- 2 UNITS
- Distribution
- US: OUS:
- Recalling firm
- UIH Technologies LLC, Houston, TX
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0217-2026 Class II | Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT…Third-party outer covers can become trapped between patient table and gantry, causing mechanical… | 09/12/2025Open, Classified |
| Z-0218-2026 Class II | Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT…Third-party outer covers can become trapped between patient table and gantry, causing mechanical… | 09/12/2025Open, Classified |
| Z-0219-2026 Class II | Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT…Third-party outer covers can become trapped between patient table and gantry, causing mechanical… | 09/12/2025Open, Classified |
| Z-0220-2026 Class II | Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT…Third-party outer covers can become trapped between patient table and gantry, causing mechanical… | 09/12/2025Open, Classified |
| Z-0221-2026 Class II | Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT…Third-party outer covers can become trapped between patient table and gantry, causing mechanical… | 09/12/2025Open, Classified |
| Z-0223-2026 Class II | Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed…Third-party outer covers can become trapped between patient table and gantry, causing mechanical… | 09/12/2025Open, Classified |
| Z-0224-2026 Class II | Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed…Third-party outer covers can become trapped between patient table and gantry, causing mechanical… | 09/12/2025Open, Classified |
| Z-0225-2026 Class II | Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed…Third-party outer covers can become trapped between patient table and gantry, causing mechanical… | 09/12/2025Open, Classified |