Positron Emission Tomography and Computed Tomography System, Model: uMI 550
Check against the official notice below — it lists the full affected range.
Shanghai United Imaging Healthcare Co., Ltd. is recalling 32 uMI 550 Positron Emission Tomography and Computed Tomography (PET/CT) systems distributed to hospitals and medical facilities in Texas, Wisconsin, California, and Michigan. The wireless vital signs monitoring (VSM) module in these systems may lose ECG and respiratory signals when operating in environments with strong Wi-Fi signals due to electromagnetic interference.
When ECG and respiratory signals are lost during a PET scan acquisition, the system may fail to properly reconstruct images using ECG and respiratory gating, potentially requiring patients to undergo repeat scanning. The recall affects devices with specific serial numbers ranging from 230002 through 230033 and 232001. The source does not specify a remedy for affected consumers or facility operators.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. Distribution: Distribution to US states of TX, WI, CA, and MI Quantity: 32 Lot/code info: UDI-DI/Serial Numbers: 06971576832026/230002, 230003, 230004, 230005, 230006, 230007, 230008, 230009, 230010, 230011, 230012, 230013, 230014, 230015, 230016, 230017, 230019, 230020, 230021, 230022, 230023, 230024, 230025, 230026, 230027, 230028, 230029, 230030, 230031, 230032, 230033, 232001
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.