Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography (PET) and Computed Tomo...
FDA Device Recall #Z-1353-2023 — Class II — March 1, 2023
Recall Summary
| Recall Number | Z-1353-2023 |
| Classification | Class II — Moderate risk |
| Date Initiated | March 1, 2023 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Shanghai United Imaging Healthcare Co., Ltd. |
| Location | Shanghai, N/A |
| Product Type | Devices |
| Quantity | 47 systems (U.S. only) |
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.
Distribution Pattern
U.S. Nationwide distribution in the state of TX. O.U.S.: Not provided.
Lot / Code Information
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
Other Recalls from Shanghai United Imaging Healthcare Co...
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0087-2023 | Class II | Positron Emission Tomography and Computed Tomog... | May 30, 2022 |
| Z-2594-2021 | Class II | uEXPLORER PET/CT System - Product Usage: intend... | Aug 2, 2021 |
| Z-2593-2021 | Class II | uMI 550 System - Product Usage: intended to be ... | Aug 2, 2021 |
| Z-1160-2021 | Class II | Digitial Medica X-ray Imagining System, Model: ... | Jan 25, 2021 |
| Z-0445-2021 | Class II | Computed Tomography X-Ray System, Model uCT 530... | Aug 5, 2020 |
Frequently Asked Questions
A software recall means the device's embedded software or firmware has a defect that could affect its performance or safety. Many software recalls are corrected through firmware updates that can be applied without physically replacing the device. For implantable devices, the update may be delivered wirelessly during a routine clinic visit. For external devices, the manufacturer may provide updated software files or replacement units. Contact your healthcare provider to determine whether your specific device and software version are affected and what action is recommended.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.