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

Class I - Dangerous

🏥 Medical Devices Recalled: March 1, 2023 Shanghai United Imaging Healthcare Co. Diagnostic Equipment Nationwide

What Should You Do?

Check if you have this product:
Models: 88000657 Serial Number/UDI Code: 230003 / 01 06971576832057 240 88000657 21 230003 230005 / 01 06971576832057 240 88000657 21 230005 230007 / 01 06971576832057 240 88000657 21 230007 230012 / 01 06971576832057 240 88000657 21 230012 230013 / 01 06971576832057 240 88000657 21 230013 230014 / 01 06971576832057 240 88000657 21 230014 230015 / 01 06971576832057 240 88000657 21 230015 230016 / 01 06971576832057 240 88000657 21 230016 230017 / 01 06971576832057 240 88000657 21 230017 230020 / 01 06971576832057 240 88000657 21 230020 230021 / 01 06971576832057 240 88000657 21 230021 230022 / 01 06971576832057 240 88000657 21 230022 230023 / 01 06971576832057 240 88000657 21 230023 230024 / 01 06971576832057 240 88000657 21 230024 230026 / 01 06971576832057 240 88000657 21 230026 230027 / 01 06971576832057 240 88000657 21 230027 230028 / 01 06971576832057 240 88000657 21 230028 230029 / 01 06971576832057 240 88000657 21 230029 230030 / 01 06971576832057 240 88000657 21 230030 230031 / 01 06971576832057 240 88000657 21 230031 230032 / 01 06971576832057 240 88000657 21 230032 230033 / 01 06971576832057 240 88000657 21 230033 230035 / 01 06971576832057 240 88000657 21 230035 230036 / 01 06971576832057 240 88000657 21 230036 230037 / 01 06971576832057 240 88000657 21 230037 230038 / 01 06971576832057 240 88000657 21 230038 230039 / 01 06971576832057 240 88000657 21 230039 230040 / 01 06971576832057 240 88000657 21 230040 230041 / 01 06971576832057 240 88000657 21 230041 230042 / 01 06971576832057 240 88000657 21 230042 230043 / 01 06971576832057 240 88000657 21 230043 230044 / 01 06971576832057 240 88000657 21 230044 230045 / 01 06971576832057 240 88000657 21 230045 230047 / 01 06971576832057 240 88000657 21 230047 230048 / 01 06971576832057 240 88000657 21 230048 Model Number: 88000057 Serial Number/UDI Code: 200017 / 01 06971576832026 240 88000057 21 200017 200023 / 01 06971576832026 240 88000057 21 200023 200024 / 01 06971576832026 240 88000057 21 200024 200036 / 01 06971576832026 240 88000057 21 200036 200045 / 01 06971576832026 240 88000057 21 200045 200047 / 01 06971576832026 240 88000057 21 200047 200059 / 01 06971576832026 240 88000057 21 200059 200071 / 01 06971576832026 240 88000057 21 200071 200072 / 01 06971576832026 240 88000057 21 200072 200075 / 01 06971576832026 240 88000057 21 200075 200078 / 01 06971576832026 240 88000057 21 200078 200079 / 01 06971576832026 240 88000057 21 200079
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Throw it away or return it: You can return the product to the store for a full refund.
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Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: Shanghai United Imaging Healthcare Co., Ltd.
Reason for Recall:: 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.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: ongoing

Product Information

Full Description:

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

Product Codes/Lot Numbers:

Models: 88000657 Serial Number/UDI Code: 230003 / 01 06971576832057 240 88000657 21 230003 230005 / 01 06971576832057 240 88000657 21 230005 230007 / 01 06971576832057 240 88000657 21 230007 230012 / 01 06971576832057 240 88000657 21 230012 230013 / 01 06971576832057 240 88000657 21 230013 230014 / 01 06971576832057 240 88000657 21 230014 230015 / 01 06971576832057 240 88000657 21 230015 230016 / 01 06971576832057 240 88000657 21 230016 230017 / 01 06971576832057 240 88000657 21 230017 230020 / 01 06971576832057 240 88000657 21 230020 230021 / 01 06971576832057 240 88000657 21 230021 230022 / 01 06971576832057 240 88000657 21 230022 230023 / 01 06971576832057 240 88000657 21 230023 230024 / 01 06971576832057 240 88000657 21 230024 230026 / 01 06971576832057 240 88000657 21 230026 230027 / 01 06971576832057 240 88000657 21 230027 230028 / 01 06971576832057 240 88000657 21 230028 230029 / 01 06971576832057 240 88000657 21 230029 230030 / 01 06971576832057 240 88000657 21 230030 230031 / 01 06971576832057 240 88000657 21 230031 230032 / 01 06971576832057 240 88000657 21 230032 230033 / 01 06971576832057 240 88000657 21 230033 230035 / 01 06971576832057 240 88000657 21 230035 230036 / 01 06971576832057 240 88000657 21 230036 230037 / 01 06971576832057 240 88000657 21 230037 230038 / 01 06971576832057 240 88000657 21 230038 230039 / 01 06971576832057 240 88000657 21 230039 230040 / 01 06971576832057 240 88000657 21 230040 230041 / 01 06971576832057 240 88000657 21 230041 230042 / 01 06971576832057 240 88000657 21 230042 230043 / 01 06971576832057 240 88000657 21 230043 230044 / 01 06971576832057 240 88000657 21 230044 230045 / 01 06971576832057 240 88000657 21 230045 230047 / 01 06971576832057 240 88000657 21 230047 230048 / 01 06971576832057 240 88000657 21 230048 Model Number: 88000057 Serial Number/UDI Code: 200017 / 01 06971576832026 240 88000057 21 200017 200023 / 01 06971576832026 240 88000057 21 200023 200024 / 01 06971576832026 240 88000057 21 200024 200036 / 01 06971576832026 240 88000057 21 200036 200045 / 01 06971576832026 240 88000057 21 200045 200047 / 01 06971576832026 240 88000057 21 200047 200059 / 01 06971576832026 240 88000057 21 200059 200071 / 01 06971576832026 240 88000057 21 200071 200072 / 01 06971576832026 240 88000057 21 200072 200075 / 01 06971576832026 240 88000057 21 200075 200078 / 01 06971576832026 240 88000057 21 200078 200079 / 01 06971576832026 240 88000057 21 200079

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1353-2023

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