Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomograp...

FDA Device Recall #Z-0223-2026 — Class II — September 12, 2025

Recall Summary

Recall Number Z-0223-2026
Classification Class II — Moderate risk
Date Initiated September 12, 2025
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm UIH Technologies LLC
Location Houston, TX
Product Type Devices
Quantity 95 units

Product Description

Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI 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:

Lot / Code Information

UDI: (01)06971576832026/ Serial Numbers: 200017 200023 200024 200036 200045 200047 230002 230003 230004 230005 230006 230007 230008 230009 230011 230010 230012 230014 230013 200059 230015 230016 230017 230019 230020 230021 230022 230023 230024 230025 232001 200071 230026 230027 200072 230028 200074 230030 230029 200075 200076 230031 230032 230033 230034 230035 200079 200078 230037 230036 230038 230039 230040 230041 230042 230043 230044 230045 230047 230048 232002 202002 232003 232004 232005 230057 232006 232007 202004 232008 232009 202005 232010 202006 232011 202007 232012 232013 232014 230067 230068 230069 232015 232016 230070 230071 230073 202008 230072 230074 232017 202009 232018 232019 202010

Other Recalls from UIH Technologies LLC

Recall # Classification Product Date
Z-0221-2026 Class II Shanghai United Imaging Healthcare Co., Ltd. ... Sep 12, 2025
Z-0224-2026 Class II Shanghai United Imaging Healthcare Co., Ltd. ... Sep 12, 2025
Z-0218-2026 Class II Shanghai United Imaging Healthcare Co., Ltd. ... Sep 12, 2025
Z-0219-2026 Class II Shanghai United Imaging Healthcare Co., Ltd. ... Sep 12, 2025
Z-0220-2026 Class II Shanghai United Imaging Healthcare Co., Ltd. ... Sep 12, 2025

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.