Day

December 21, 2016
Company: Olympus Corporation of the Americas Date of Enforcement Report 12/21/2016 Class lI: PRODUCT HF Cable WA00014A, Endoscopic electrosurgical unit and accessories Recall Number Z-0754-2017 REASON Software malfunction that results in incorrect generation or display of error codes. RECALLING FIRM/MANUFACTURER Olympus Corporation of the Americas, Center Valley, PA on 11/3/2016. Voluntary: Firm Initiated recall is...
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Company: Beckman Coulter Inc.Date of Enforcement Report 12/21/2016 Class lI: PRODUCT MicroScan LabPro Data Management System. Intended to manage both microbial identification (ID) and antimicrobial agent susceptibility testing (AST) data generated from MicroScan instruments or manually entered microbiology test results, for use by trained laboratory personnel. Recall Number Z-0768-2017 REASON Beckman Coulter has received and...
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Company: Merge Healthcare, Inc. Date of Enforcement Report 12/21/2016 Class lI: PRODUCT Merge Cardio software. Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information from Camtronics and other vendors systems including images, hemodynamic studies and reports, measurements (via import from DICOM Structured reporting, text files or...
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Company: Merge Healthcare, Inc. Date of Enforcement Report 12/21/2016 Class lI: PRODUCT Merge Cardio software. Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information including images, Hemodynamic studies and reports, measurements (via import from DICOM Structured Reporting, text files or optical character recognition of measurements captured...
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