Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography (PET) and Computed Tomography (CT), Model uMI 550 Part Number: 88000657 88000057
FDA Recall Z-1353-2023 · Posted 2023-04-07
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Recalling FirmShanghai United Imaging Healthcare Co., Ltd.
Recall StatusOpen, Classified
Product CodeKPS
Date Initiated2023-03-01
Product Quantity47 systems (U.S. only)
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.
Firm Action
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).
Root Cause
Software design
Distribution Pattern
U.S. Nationwide distribution in the state of TX. O.U.S.: Not provided.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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