Lower riskMedical device recall · FDA · Published March 1, 2023
Shanghai United Imaging Healthcare uMI PET/CT Scanners: Software Issue May Cause Image
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.
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.
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 PET/CT Scanners: Software Issue May Cause Image.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58811-shanghai-united-imaging-healthcare-umi-pet-ct-scanners-software-issue. Based on FDA recall #Z-1353-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1353-2023%22&limit=1).
Shanghai United Imaging Healthcare Co., Ltd. recalled Positron Emission Tomography (PET) and Computed Tomography (CT), Model uMI devices due to a software issue that may cause PET image reconstruction failure, the FDA said on March 1, 2023.
How to tell if you have it
Brand: Shanghai United Imaging Healthcare
Product: Positron Emission Tomography (PET) and Computed Tomography (CT), Model uMI
Part Number: 88000657, 88000057
Model Number: 88000657, 88000057
Serial Numbers/UDI Codes: 230003 through 230048 (Part 88000657); 200017 through 200079 (Part 88000057)
Units affected: 47 systems
The hazard
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.
Context
GovInfoNow's records show Shanghai United Imaging Healthcare Co., Ltd. has 14 other recalls on record since July 30, 2019. Other recent recalls of similar products include Computed Tomography X-ray System Recall (August 11, 2026), uMI 550 PET/CT System Recall (May 30, 2022), and uEXPL: PET/CT System Recall (August 2, 2021). Other recent recalls of similar products include Philips Incisive CT Recall (December 3, 2025), GE Healthcare Omni Legend PET Scanners recall (December 24, 2025), and Philips Achieva 3.0T MRI Recalled (August 21, 2026).
How to tell if you have this one
Check if your scanner has model number 88000657 or 88000057 with serial numbers starting with 230003 or 200017 as listed in the recall notice. The affected units were sold with specific part numbers and serial codes.
Brand
Shanghai United Imaging Healthcare
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Scanner Details
Verify your scanner's model number and serial number against the list of affected units provided in the recall notice.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “U.S. Nationwide distribution in the state of TX. O.U.S.: Not provided.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 49 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
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-1353-2023 (March 1, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1353-2023 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.