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.
Potential sporadic software bugs in R001.3.0.0.750505 software version may cause an issue with the PET acquisition raw data causing reconstruction problems during PET/CT scanning and could possibly cause rescans of patients with additional dose.
Take action
Contact the company
📍Recalling firmShanghai United Imaging Healthcare Co., Ltd.No. 2258 Chengbei Rd, Jiading Ind. · Shanghai, China
“Shanghai United Imaging Healthcare uMI 550 PET/CT Scanner Software Recalls: Potential.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/67106-shanghai-united-imaging-healthcare-umi-550-pet-ct-scanner-software. Based on FDA recall #Z-1708-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1708-2020%22&limit=1).
The FDA announced on 2019-08-26 that Shanghai United Imaging Healthcare Co., Ltd. is recalling two Positron Emission Tomography and Computed Tomography Systems, Model uMI 550, with software version R001.3.0.0.750505 due to potential sporadic software bugs. These bugs may cause reconstruction problems during PET/CT scanning and could possibly lead to patient rescans with additional radiation dose.
Distribution: US Nationwide distribution in the state TX
The hazard
The potential sporadic software bugs in R001.3.0.0.750505 software version may cause an issue with the PET acquisition raw data causing reconstruction problems during PET/CT scanning and could possibly cause rescans of patients with additional dose.
Context
GovInfoNow's records show Shanghai United Imaging Healthcare Co., Ltd. has 14 other recalls on record since 2019-07-30. Other recent recalls of similar products include Positron Emission Tomography and Computed Tomography System, Model: uMI 550 with software (2026-08-11), Shanghai United Imaging Healthcare uMI PET/CT Scanners: Software Issue May Cause Image Reconstruction Failure (2023-03-01), and Shanghai United Imaging Healthcare uMI 550 PET/CT System Recall: Wi-Fi Interference May Cause Scan Failures (2022-05-30). Other recent recalls of similar products include Philips Ingenuity CT Scanners: Unintended Radiation Risk (2026-08-07), Philips Brilliance CT Scanners: Unintended Radiation Risk in Software 4.1.10.x (2026-08-07), and Philips IQon Spectral CT Software 4.7.7.x Recall: Unintended Radiation Risk (2026-08-07).
How to tell if you have this one
Check for the model uMI 550 with software version R001.3.0.0.750505. Affected units have serial numbers 200017 and 200023. The product is intended for use by healthcare professionals in medical settings.
Brand
Shanghai United Imaging Healthcare
Product
Positron Emission Tomograpy and Computed Tomography System, Model: uMI 550, with software version R001.3.0.0.750505, Rx
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Verify the software version on your uMI 550 scanner; affected units have version R001.3.0.0.750505.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide distribution in the state TX.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2.7 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1708-2020 (August 26, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1708-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.