FDA Device recall Z-1353-2023
Shanghai United Imaging Healthcare Co., Ltd
- FDA Device
- Class II
- ongoing
- Published 2023-04-19
On 2023-04-19 the FDA classified a Class II recall of Shanghai United Imaging Healthcare Co., Ltd by Shanghai United Imaging Healthcare, citing 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 a….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1353-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-03-01 |
| Published | 2023-04-19 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Shanghai United Imaging Healthcare |
| Distribution | US |
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.
Identifiers
| code_info | Models: 88000657 Serial Number/UDI Code: 230003 / 01 06971576832057 240 88000657 21 230003 230005 / 01 06971576832057…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1353-2023%22
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