Lower riskMedical device recall · FDA · Published May 30, 2022
Shanghai United Imaging Healthcare uMI 550 PET/CT System Recall: Wi-Fi Interference May
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.
The wireless VSM module of a mobile PET/CT system, operating in an environment with strong Wi-Fi signals, may experience ECG signal and respiratory signal loss due to Wi-Fi interference. ECG and respiratory signal loss during acquisition can result in the failure of ECG and respiratory-gated reconstruction of the PET scan, which may require rescanning of the patient.
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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 System Recall: Wi-Fi Interference May.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60576-shanghai-united-imaging-healthcare-umi-550-pet-ct-system-recall. Based on FDA recall #Z-0087-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0087-2023%22&limit=1).
The FDA announced on May 30, 2022, that Shanghai United Imaging Healthcare Co., Ltd. is recalling its uMI 550 Positron Emission Tomography and Computed Tomography Systems. The recall addresses potential ECG and respiratory signal loss due to Wi-Fi interference.
Serial Numbers: 230002 through 230017, 230019 through 230033, 232001
The hazard
The wireless VSM module may experience ECG and respiratory signal loss in environments with strong Wi-Fi signals. This interference can result in the failure of ECG and respiratory-gated reconstruction of the PET scan, which may require rescanning of the patient.
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, Model: uCT 550 (August 11, 2026), uMI PET/CT Scanners software issue (March 1, 2023), and uMI 550 System workflow freeze (August 2, 2021). Other recent recalls of similar products include Philips Incisive CT Recall (December 3, 2025), Philips Smart-hopping 2.0 AP 1.4 GHz Patient Monitor Recall (December 12, 2025), and GE HealthCare Telemetry Server Recall (April 24, 2026).
How to tell if you have this one
Check for serial numbers starting with 06971576832026 or 230001-232001 on the uMI 550 PET/CT system. The system is sold by Shanghai United Imaging Healthcare.
Brand
Shanghai United Imaging Healthcare
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Serial Numbers
Look for serial numbers starting with 06971576832026 or 230001-232001 on the uMI 550 PET/CT system.
Where it went and when
Where it was distributed
Distributed in 4 states.
Listed by the agency
Not listed
FDA distribution: “Distribution to US states of TX, WI, CA, and MI” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Michigan, Texas, Wisconsin.
Recall timeline
FDA published this recall 5 months 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-0087-2023 (May 30, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0087-2023 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.