07
Apr
2023

Recall: Software Issue May Cause Failure of PET Images

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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.

About the author

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

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