April 15, 2020
Company: Radiometer Medical ApS Date of Enforcement Report: 4/15/2020 Class II PRODUCT ABL800 FLEX, model number/UDI 393-800/0570 In Vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl , cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF)....
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Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report: 4/15/2020 Class II PRODUCT ARTISTE MV System Model #8139789 with Digital LINAC Systems Control Console Software Versions 6, 7, 9, 13 Recall Number: Z-1677-2020 REASON Potential safety issue with the dose monitoring system safety interlocks which could result in a 10-20% overdose of radiation therapy....
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Company: Change Healthcare Canada Company Date of Enforcement Report: 4/15/2020 Class II PRODUCT McKesson Cardiology ECG Management, Change Healthcare Cardiology ECG Management Recall Number: Z-1682-2020 REASON Inaccurate estimation of the heart rate may occur in instances where the user is estimating heart rate counting grid squares using the Sequential ECG format. RECALLING FIRM/MANUFACTURER Change Healthcare...
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Company: Beckman Coulter Inc. Date of Enforcement Report: 4/15/2020 Class II PRODUCT LabPro Data Management System, UDI: 15099590676872 – Product Usage: The LabPro Data Management System is a Microsoft Windows based software program and is intended to manage both microbial identification (ID) and antimicrobial agent susceptibility testing (AST) data generated from MicroScan instruments or manually...
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Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

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