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Recall Observatory FDA recall evidence

Device product

Positron Emission Tomography and Computed Tomography System, Model: uMI 550

Z-0087-2023

May 30, 2022

Class II

Product summary

Firm
Shanghai United Imaging Healthcare Co., Ltd.
Event
Event 90888
Status
Ongoing
Classification
Class II
Quantity
32
Official record key
device-enforcement:Z-0087-2023

Official wording

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.

Code information: 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

Distribution pattern: Distribution to US states of TX, WI, CA, and MI

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.