Z-0087-2023 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- October 19, 2022
- Initiation Date
- May 30, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 32
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.
Distribution Pattern
Distribution to US states of TX, WI, CA, and MI
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