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.
Shanghai United Imaging Healthcare is recalling uMI 550 PET/CT systems that may lose ECG and respiratory signals when used near strong Wi-Fi signals. This could cause scans to fail and require rescanning, which may delay diagnosis or treatment.
The wireless VSM module in the system can lose ECG and respiratory signal data when exposed to strong Wi-Fi signals. This causes the PET scan to fail in reconstructing images properly, potentially requiring the patient to undergo a rescan.
Medical facilities using the uMI 550 PET/CT systems with the listed serial numbers are most affected. Patients undergoing scans with these systems may experience delays if rescans are needed.
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.
Look for serial numbers starting with 06971576832026 or 230001-232001 on the uMI 550 PET/CT system.
The wireless VSM module may lose ECG and respiratory signals when near strong Wi-Fi signals, causing scan failures that might require rescans.
Check the serial numbers on the system. If they match the recalled range, contact Shanghai United Imaging Healthcare for further instructions.
The recall does not mention any risk of injury to patients or staff. The issue is limited to scan failures requiring rescans.
We’ve drafted a message you can send Shanghai United Imaging Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0087-2023 — Shanghai United Imaging Healthcare Shanghai United Imaging Healthcare Hello, I own a Shanghai United Imaging Healthcare that is covered by recall Z-0087-2023 from Shanghai United Imaging Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
