Home / Recalls / Shanghai United Imaging Healthcare Co., Ltd. / Z-1353-2023

Z-1353-2023 Class II Ongoing

Recalled by Shanghai United Imaging Healthcare Co., Ltd. — Shanghai, N/A

Recall Details

Product Type
Devices
Report Date
April 19, 2023
Initiation Date
March 1, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
47 systems (U.S. only)

Product Description

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

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.

Distribution Pattern

U.S. Nationwide distribution in the state of TX. O.U.S.: Not provided.

Code Information

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

Other recalls by Shanghai United Imaging Healthcare Co., Ltd.

  • Z-0087-2023 Class II — Positron Emission Tomography and Computed Tomography System, Model: uMI 550 (May 30, 2022)
  • Z-2594-2021 Class II — uEXPLORER PET/CT System - Product Usage: intended to be operated by qualified he (August 2, 2021)
  • Z-2593-2021 Class II — uMI 550 System - Product Usage: intended to be operated by qualified healthcare (August 2, 2021)
  • Z-1160-2021 Class II — Digitial Medica X-ray Imagining System, Model: uDR 596i, RX, CE0123, UDI:(01) 06 (January 25, 2021)
  • Z-0446-2021 Class II — Computed Tomography X-Ray System, Model uCT 550, Rx, CE, GTIN: 06971576831036 - (August 5, 2020)
  • Z-0448-2021 Class II — Positron Emission Tomography and Computed Tomography System, Model uMI 550, Rx, (August 5, 2020)
  • Z-0447-2021 Class II — Computed Tomography X-Ray System, Model uCT 760, Rx, CE, GTIN: 06971576831043 - (August 5, 2020)
  • Z-0445-2021 Class II — Computed Tomography X-Ray System, Model uCT 530, Rx, CE, GTIN: 06971576831012 - (August 5, 2020)
  • Z-2799-2020 Class II — uEXPLORER PET/CT Diagnostic Imaging System - Product Usage: This system is inten (July 16, 2020)
  • Z-2800-2020 Class II — uMI 550 PET/CT Diagnostic Imaging System - Product Usage: This system is intende (July 16, 2020)