Company: Philips Medical Systems, Inc. Date of Enforcement Report 10/29/2014 Class lI: PRODUCT Philips IntelliVue Monitors with software revisions J.21.03, J.21.19. Model Product MP5 M8105A; MP5SC M8105AS; MP5T M8105AT; MP5 Upgrade M8105AU ; MP5SC Upgrade 866327 The monitors are intended to be used for monitoring and recording of, and to generate alarms for, multiple physiological...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 10/29/2014 Class lI: PRODUCT Philips Avalon Monitors with software revision J.30.58: Model Product FM20 M2702A ; FM30 M2703A ; FM50 M2705A Intended for: ” Monitoring the physiological parameters of pregnant women ” Non-invasive monitoring of fetal heart rates and movements. Recall Number Z-0105-2015 REASON Philips Intellivue...Read More

Company:Mindray DS USA, Inc. dba Mindray North America.Date of Enforcement Report: 10/29/2014 Class lI: PRODUCT Mindray V21, Size: 515 mm X 335 mm X 685 mm, N.W.: 8 kg, G.W.: 11 kg, Qty:1 The V-Series Monitor is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner. The indications for use...Read More