Positron Emission Tomography and Computed Tomography System, Model: uMI 550
Reported: October 19, 2022 Initiated: May 30, 2022 #Z-0087-2023
Product Description
Positron Emission Tomography and Computed Tomography System, Model: uMI 550
Reason for Recall
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.
Details
- Recalling Firm
- Shanghai United Imaging Healthcare Co., Ltd.
- Units Affected
- 32
- Distribution
- Distribution to US states of TX, WI, CA, and MI
- Location
- Shanghai, N/A
Frequently Asked Questions
What product was recalled? ▼
Positron Emission Tomography and Computed Tomography System, Model: uMI 550. Recalled by Shanghai United Imaging Healthcare Co., Ltd.. Units affected: 32.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 19, 2022. Severity: Moderate. Recall number: Z-0087-2023.
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