Recall Z-1353-2023— Shanghai United Imaging Healthcare Co., Ltd.
Class II · Ongoing
Class II FDA medical device recall by Shanghai United Imaging Healthcare Co., Ltd., initiated 2023-03-01. It names 2 FDA 510(k) clearances: K193241, K182237. Product: Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography (PET) and Computed Tomography (CT), Model uMI 550 Part Number: 88000657 88000057. Reason: 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..
- Recalling firm
- Shanghai United Imaging Healthcare Co., Ltd.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-03-01
- Firm location
- Shanghai, N/A, China
510(k) clearances named in this recall
2 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.