Recall Z-0087-2023— Shanghai United Imaging Healthcare Co., Ltd.
Class II · Ongoing
Class II FDA medical device recall by Shanghai United Imaging Healthcare Co., Ltd., initiated 2022-05-30. It names 2 FDA 510(k) clearances: K193241, K182237. Product: Positron Emission Tomography and Computed Tomography System, Model: uMI 550. Reason: 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..
- Recalling firm
- Shanghai United Imaging Healthcare Co., Ltd.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-05-30
- Firm location
- Shanghai, N/A, China
510(k) clearances named in this recall
2 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.