April 22, 2020
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., 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,...
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Company: Abbott Date of Enforcement Report: 4/22/2020 Class II PRODUCT Merlin PCS 3650 Software Upgrade Kit, REF 3330 St. Jude Medical The MerlinTM Patient Care System (MerlinTM PCS) Model 3650 is a portable, dedicated programming system designed to interrogate, program, display data, and test St. Jude MedicalTM implantable devices and leads. Recall Number: Z-1700-2020 REASON...
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Company: Sysmex America, Inc. Date of Enforcement Report: 4/22/2020 Class II PRODUCT The CF-70 instrument (product code: LXG; Regulation Number: 862.2050) receives magazines containing stained blood smears from SP-50, selects only smears that require analysis, and transports them to the DI-60 for further analysis. After completing the analysis on DI-60 the smears are placed back...
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Company: Canon Medical System, USA, INC. Date of Enforcement Report: 4/22/2020 Class II PRODUCT Canon Aquilion Lightning, Model TSX-036A Recall Number: Z-1719-2020 REASON Scanning may be interrupted due to an error during execution of the eXam Plan and the system is unable to be shut down normally, resulting in the need to forcibly turn the...
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