Company: Philips Electronics North America Corporation Date of Enforcement Report 10/26/2016 Class lI: PRODUCT Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 Smart-hopping (2.4GHz) Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring and recording of, and to generate alarms for, multiple physiological...Read More

Company: Philips Electronics North America Corporation Date of Enforcement Report 10.262016 Class lI: PRODUCT Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 WMTS Smart-hopping (1.4GHz) Product Number: 865350 Exchange part: 453564262491 453564262511 453564615311 453564615331 453564262571 453564262591 USA only SW Revisions: B.05.28, B.05.29, and B.05.32 Indicated for use by health care professionals whenever there is a need...Read More

Company: Philips Electronics North America Corporation Date of Enforcement Report 10/26/2016 Class lI: PRODUCT Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 802.11a/b/g Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters...Read More

Company: Merge Healthcare, Inc. Date of Enforcement Report 10/26/2016 Class lI: PRODUCT Fusion Workstation.; Indicated for the transmission and review of radiological images. Recall Number Z-0294-2017 REASON After a period of time running Fusion Workstation, the Hounsfield measurement tool will report incorrect values. RECALLING FIRM/MANUFACTURER Merge Healthcare, Inc., Hartland, WI on 10/20/2016. Voluntary: Firm Initiated...Read More

Company: Merge Healthcare, Inc. Date of Enforcement Report 9/14/2016 Class lI: PRODUCT CADstream software Product Usage: CADstream is an image processing system designed to assist in the visualization, analysis, and reporting of magnetic resonance imaging (MRI) studies. CADstream also is intended to provide workflow efficiency and interventional planning tools. Recall Number Z-0118-2017 REASON Customers may...Read More