Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography (PET) and Computed Tomography (CT), Model uMI 550 Part Number: 88000657 88000057
Reported: April 19, 2023 Initiated: March 1, 2023 #Z-1353-2023
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.
Details
- Recalling Firm
- Shanghai United Imaging Healthcare Co., Ltd.
- Units Affected
- 47 systems (U.S. only)
- Distribution
- U.S. Nationwide distribution in the state of TX. O.U.S.: Not provided.
- Location
- Shanghai, N/A
Frequently Asked Questions
What product was recalled? ▼
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography (PET) and Computed Tomography (CT), Model uMI 550 Part Number: 88000657 88000057. Recalled by Shanghai United Imaging Healthcare Co., Ltd.. Units affected: 47 systems (U.S. only).
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 19, 2023. Severity: Moderate. Recall number: Z-1353-2023.
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