Company: Shanghai United Imaging Healthcare Co., Ltd
Date of Enforcement Report: 4/7/2023
Class II
PRODUCT
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography (PET) and Computed Tomography (CT), Model uMI 550 Part Number: 88000657 88000057
Recall Number:
Z-1353-2023
REASON:
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.
RECALLING FIRM/MANUFACTURER:
Shanghai United Imaging Healthcare Co., Ltd.
VOLUME OF PRODUCT IN COMMERCE:
47 systems (U.S. only)
DISTRIBUTION:
U.S. Nationwide distribution in the state of TX. O.U.S.: Not provided.
