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uMI recallZ-1353-2023 · Shanghai United Imaging Healthcare Co., Ltd. · initiated Mar 1, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Shanghai United Imaging Healthcare Co., Ltd. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Software design

What the company is doing

On 03/01/2023, the firm sent an "Advisory Notification: Positron Emission Tomography and Computed Tomography System (PET/CT)" Letter via email to customers informing them that, the scatter correction may fail due to GPU (Graphic Processing Unit) memory access exception. The failure of the scatter correction could result in the failure of the PET image reconstruction. Customers are instructed to: 1. if the default PET image reconstruction fails with an error information of abnormal GPU status, but the reconstruction without either attenuation correction or scatter correction works successfully, the following actions are suggested to be applied: 1) Try using the diagnostic CT image series instead of ACCT image series for attenuation correction to repeat the PET reconstruction. It may resolve the error issue, but the quantification of PET image might be affected due to attenuation correction with using the limited field of view of diagnostic CT image. If the resulted PET image is insufficient for diagnosis, try second suggestion. 2) Try re-perform the PET acquisition, the reconstruction may succeed. 3) Contact the United Imaging service engineer to install the updated software to resolve the issue, and offline reconstruct the PET image. For questions, contact United Imaging service engineer or call the United Imaging Customer Contact Center (24- hour hotline) at 855-221-1552 (toll-free) or 832-699-2799 (direct).

Recall details

Recall number
Z-1353-2023
Status
Open, Classified
Initiated by the company
Mar 1, 2023
Posted by the FDA
Apr 7, 2023
Recalling firm
Shanghai United Imaging Healthcare Co., Ltd.
Quantity
47 systems (U.S. only)
Product code
KPS
FDA submissions
K182237, K193241
Distribution
U.S. Nationwide distribution in the state of TX. O.U.S.: Not provided.

Product description

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

Code information (models, lots, serial numbers)

Show the full code information (2k characters)

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

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Sources and updates

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