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

Recall Z-1353-2023 — Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography (PET) and Computed Tomography (CT), Model uMI 550 Part Number: 88000657 88000057

U.S. FDA — Device Enforcement · China · 2023-03-01 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1353-2023
Date of alert
2023-03-01
Country / jurisdiction
China
Risk level
Class II
Risk type
recall
Brand
Shanghai United Imaging Healthcare Co., Ltd.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
88000657
Reported risk: Due to a software issue where the process of patient scanning, the scatter correction may occasionally fail with will potentially cause a failure of the PET image reconstruction and generation of PET images.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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