Company: Shanghai United Imaging Healthcare Co., Ltd.
Date of Enforcement Report: 4/22/2020
Class II
PRODUCT
Positron Emission Tomograpy and Computed Tomography System, Model: uMI 550, with software version R001.3.0.0.750505, Rx Only, CE 0197, UDI: (01)06971576832026 – Product Usage: This system is intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and disorders in, but not limit to, oncology, cardiology and neurology.
Recall Number: Z-1708-2020
REASON
Potential sporadic software bugs in R001.3.0.0.750505 software version may cause an issue with the PET acquisition raw data causing reconstruction problems during PET/CT scanning and could possibly cause rescans of patients with additional dose.
RECALLING FIRM/MANUFACTURER
Shanghai United Imaging Healthcare Co., Ltd. on 8/26/2019. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
US Nationwide