Shanghai United Imaging Healthcare Co., Ltd. recalls
Every recall we track for Shanghai United Imaging Healthcare Co., Ltd. — 33 in all, from 2019–2026 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
Recalls from Shanghai United Imaging Healthcare Co., Ltd. peaked in 2020 (14); 33 since 2017.
All FDA recall records for Shanghai United Imaging Healthcare Co., Ltd. since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 2 | 0 | 2 |
| 2020 | 0 | 1 | 13 | 0 | 14 |
| 2021 | 0 | 1 | 2 | 0 | 3 |
| 2022 | 0 | 0 | 1 | 0 | 1 |
| 2023 | 0 | 0 | 1 | 0 | 1 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2026 (to date) | 0 | 0 | 1 | 11 | 12 |
What to do if you have a recalled Shanghai United Imaging Healthcare Co., Ltd. product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Shanghai United Imaging Healthcare Co., Ltd. recalls
15 shown- Lower riskMedical device
Shanghai United Imaging Healthcare Co., Ltd. recalls Computed Tomography X-ray System, Model: uCT 530 with software
Shanghai United Imaging Healthcare recalls CT X-ray system uCT 530 with software issue that prevents patient images from being visible on the Patient Administration interface, requiring rescans.
Shanghai United Imaging HealthcareAug 11, 2026 - Lower riskMedical device
Shanghai United Imaging Healthcare Co., Ltd. recalls Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography (PET) and Computed Tomography (CT), Model uMI
Shanghai United Imaging Healthcare recalls uMI PET/CT scanners with software issue that may cause PET image reconstruction failure during scans. Affected models include uMI 550 with specific serial numbers and part numbers listed.
Shanghai United Imaging HealthcareMar 1, 2023 - Lower riskMedical device
Shanghai United Imaging Healthcare Co., Ltd. recalls Positron Emission Tomography and Computed Tomography System, Model: uMI 550
Shanghai United Imaging Healthcare recalls uMI 550 PET/CT systems with serial numbers 06971576832026/230001-232001 due to Wi-Fi interference causing ECG/respiratory signal loss during scans, potentially requiring rescans.
Shanghai United Imaging HealthcareMay 30, 2022 - Lower riskMedical device
Shanghai United Imaging Healthcare Co., Ltd. recalls uEXPLORER PET/CT System - Product Usage: intended to be operated by qualified healthcare professionals to assist in the
Shanghai United Imaging Healthcare recalls uEXPLORER PET/CT systems due to occasional workflow freezes after canceling PET scans. Affected units may require professional evaluation.
Shanghai United Imaging HealthcareAug 2, 2021 - Use cautionMedical device
Shanghai United Imaging Healthcare Co., Ltd. recalls Digitial Medica X-ray Imagining System, Model: uDR 596i, RX, CE0123, UDI:(01) 06971576833023 - Product Usage: intended
Shanghai United Imaging Healthcare recalls uDR 596i X-ray systems with potential for uncommanded motion causing patient collisions. Affected units have specific serial numbers. Contact for remedy.
Shanghai United Imaging HealthcareJan 25, 2021 - Lower riskMedical device
Shanghai United Imaging Healthcare Co., Ltd. recalls Positron Emission Tomography and Computed Tomography System, Model uMI 550, Rx, CE, GTIN: 06971576832026 - Product
Shanghai United Imaging Healthcare recalls uMI 550 CT scanners due to potential incorrect radiation exposure during scans. Affected units have serial numbers 200017, 200023, 200024, 200036, 200045, 200047, 230002, 230003, 230004.
Shanghai United Imaging HealthcareAug 5, 2020 - Use cautionMedical device
Shanghai United Imaging Healthcare Co., Ltd. recalls uEXPLORER PET/CT Diagnostic Imaging System - Product Usage: This system is intended to be operated by qualified
Shanghai United Imaging Healthcare recalls uEXPLORER PET/CT scanners that may cause image artifacts and scanning interruptions due to signal drift. Affected units have serial numbers starting with F00002.
Shanghai United Imaging HealthcareJul 16, 2020 - Lower riskMedical device
Shanghai United Imaging Healthcare Co., Ltd. recalls Computed Tomography X-ray System; Model uCT 530; Rx; UDI: (01) GTIN: 06971576831012 - Product Usage: intended to
Shanghai United Imaging Healthcare recalls uCT 530 CT scanners with uneven metal edges that could cause sharp injuries. Affected units have specific serial numbers and were sold with certain GTINs. Contact for repair or replacement.
Shanghai United Imaging HealthcareJun 20, 2020 - Lower riskMedical device
Shanghai United Imaging Healthcare Co., Ltd. recalls Computed Tomography X-ray System, Model: uCT 550, GTIN: 06971576831036 Intended use The uCT Computed Tomography X-ray
Shanghai United Imaging Healthcare recalls uCT 550 CT scanners with serial numbers 353020-353023 (software R001.11.0.729741-Re-1100) due to potential false channel marking causing extra radiation exposure and rescan needs.
Shanghai United Imaging HealthcareMay 23, 2020 - Lower riskMedical device
Shanghai United Imaging Healthcare Co., Ltd. recalls uCT 530 Computed Tomography X-Ray System
Shanghai United Imaging Healthcare recalls uCT 530 CT scanners with software version R001.11.0.729741-Re-1100 due to potential false channel marking and radiation exposure risks from rescan needs.
Shanghai United Imaging HealthcareMay 8, 2020 - Lower riskMedical device
Shanghai United Imaging Healthcare Co., Ltd. recalls uCT 760 System, Computed Tomography X-ray System
Shanghai United Imaging Healthcare recalls uCT 760 CT scanners with specific serial numbers and software versions due to potential image artifacts and radiation dose increases from rescanning.
Shanghai United Imaging HealthcareMay 8, 2020 - Lower riskMedical device
Shanghai United Imaging Healthcare Co., Ltd. recalls Positron Emission Tomography and Computed Tomography System, Model: uMI 550, Material Number: 88000057 - Product Usage:
Shanghai United Imaging Healthcare recalls uMI 550 CT scanners with specific software versions due to potential image display issues during bolus tracking. Affected units may require manual scanning, risking patient rescan. Contact for remedy details.
Shanghai United Imaging HealthcareMar 26, 2020 - Lower riskMedical device
Shanghai United Imaging Healthcare Co., Ltd. recalls uDR 596i Digital Medical X-Ray Imaging System - Product Usage: intended to use by a qualified/ trained doctor or
Shanghai United Imaging Healthcare recalls uDR 596i X-Ray Systems with software versions R002.19.0-1.8402-690106 and R002.19.0.8648.690112 due to incorrect anatomical positioning and potential radiation exposure risks.
Shanghai United Imaging HealthcareFeb 27, 2020 - Lower riskMedical device
Shanghai United Imaging Healthcare Co., Ltd. recalls Positron Emission Tomograpy and Computed Tomography System, Model: uMI 550, with software version R001.3.0.0.750505, Rx
Shanghai United Imaging Healthcare recalls uMI 550 PET/CT scanners with specific software version R001.3.0.0.750505 due to potential PET acquisition data issues that could lead to rescans and additional patient radiation doses. Affected units have serial numbers 200017 and 200023.
Shanghai United Imaging HealthcareAug 26, 2019 - Lower riskMedical device
Shanghai United Imaging Healthcare Co., Ltd. recalls Digital Medical X-ray Imaging System, Model: uDR 596i, uDR 592h
Shanghai United Imaging Healthcare recalls uDR 596i and uDR 592h X-ray systems due to reversed spine positioning labels, risking repeat patient exposures. Affected units have specific serial numbers and were sold with certain DI/GTIN codes.
Shanghai United Imaging HealthcareJul 30, 2019
Shanghai United Imaging Healthcare Co., Ltd. recall questions
How many recalls has Shanghai United Imaging Healthcare Co., Ltd. had?
33 recalls from Shanghai United Imaging Healthcare Co., Ltd. are on record with U.S. safety agencies, from 2019–2026.
What is the most recent Shanghai United Imaging Healthcare Co., Ltd. recall?
Shanghai United Imaging Healthcare Co., Ltd. recalls Computed Tomography X-ray System, Model: uCT 530 with software, dated Aug 11, 2026. Every Shanghai United Imaging Healthcare Co., Ltd. recall is listed on this page, newest first.
What should I do if I have a recalled Shanghai United Imaging Healthcare Co., Ltd. product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Shanghai United Imaging Healthcare Co., Ltd. recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.