Official recall record
Positron Emission Tomography and Computed Tomography System, Model: uMI 550 with software
- Issuing authority
- US FDA — Medical Devices
- Alert date
- 2026-08-11
- Country of alert
- China
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 06971576832026
- Brand on record
- Shanghai United Imaging Healthcare Co., Ltd.
What the authority reported
Positron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS exams are merged into a single study, that prevents patient images from being visible on the Patient Administration interface, which may result in the need for rescans.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-10-22.
Record last checked against the registry on 2026-10-22.
Same barcode in other registries
The same EAN appears in 4 other official recall record(s) — a cross-border signal worth checking if you bought this product abroad.
- 2020-03-26 · US FDA — Medical Devices
Positron Emission Tomography and Computed Tomography System, Model: uMI 550, Material Number: 88000057 - Product Usage: - 2025-09-12 · US FDA — Medical Devices
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI 55 - 2020-08-05 · US FDA — Medical Devices
Positron Emission Tomography and Computed Tomography System, Model uMI 550, Rx, CE, GTIN: 06971576832026 - Product Usag - 2022-05-30 · US FDA — Medical Devices
Positron Emission Tomography and Computed Tomography System, Model: uMI 550
Other recalls from this brand
- 2026-08-11 · US FDA — Medical Devices
Computed Tomography X-ray System, Model: uCT 550 with software - 2026-08-11 · US FDA — Medical Devices
Computed Tomography X-ray System, Model: uCT 530 with software - 2026-08-11 · US FDA — Medical Devices
Positron Emission Tomography and Computed Tomography System, Model: uMI Panorama 35 with software
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