Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0224-2026 — Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI 780 MD, Rx Only

U.S. FDA — Device Enforcement · United States · 2025-09-12 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0224-2026
Date of alert
2025-09-12
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
UIH Technologies LLC
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
06971576832033
Reported risk: Third-party outer covers can become trapped between patient table and gantry, causing mechanical interference during table movement.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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