Day

March 7, 2018
Company:ZOLL Medical Corporation Date of Enforcement Report 3/7/2018 Class lI: PRODUCT 731 Series Ventilators running software version 05.20.00 The devices in the ZOLL ventilator are indicated for use in the management of infant through adult patients weighing ;:: 5 kg with acute or chronic respiratory failure or during resuscitation by providing continuous positive-pressure ventilation. Recall...
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Company:Philips Electronics North America Corporation Date of Enforcement Report 3/7/2018 Class lI: PRODUCT digital x-ray detector ProGrade R1 – solid state X ray imager (flat panel/digital imager) As a part of a radiographic system, the Philips ProGrade is intended to acquire, process, store, display, and export digital radiographic images. The Philips ProGrade is suitable for...
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Company:Philips Electronics North America Corporation Date of Enforcement Report 3/7/2018 Class lI: PRODUCT Intellivue iX Information Center Software – All PIIC iX Surveillance stations including: 866023 IntelliVue Info Center iX A.0 866117 PIIC Classic Upgrade 866389 IntelliVue Info Center iX B.0, C.0 867141 IntelliVue Info Center iX B.0 866025 IntelliVue Server IX A.0 866118 Database...
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Company:Fresenius Medical Care Renal Therapies Group, LLC Date of Enforcement Report 3/7/2018 Class lI: PRODUCT Intellivue iX Information Center Software – All PIIC iX Surveillance stations including: 866023 2008T, Hemodialysis Delivery System Product Indicated for acute and chronic dialysis therapy. Recall Number Z-0829-2018 REASON While reviewing documentation for the next software release of the 2008T,...
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