Company: Vidco Inc.Date of Enforcement Report 1/13/2016 Class lI: PRODUCT Remote Patient Monitoring System, MDP 2000 Series, Part Numbers: MDP2040-0100, PGM340R3, or PGM340R4. The MDP2000 is intended for use in conjunction with patient monitoring equipment. The MDP2000 is not patient connected Examples of areas where the MDP200 is used include ICU, CCU, PACU, Emergency, Telemetry...Read More

Company: Siemens Medical Solutions USA, Inc.Date of Enforcement Report 1/13/2016 Class lI: PRODUCT Software version VD10E for Syngo X-Workplace; Picture archiving and communication system. Recall Number Z-0597-2016 REASON Potential post-processing software issue when using tabcard “4D” on X-Workplace with software version VD10E. A too small measurement in the MPRs of a volume when images are...Read More

Company: Philips Ultrasound Inc Date of Enforcement Report 1/13/2016 Class lI: PRODUCT Philips Lumify Diagnostic Ultrasound, Catalogue Number: 795216 Part Number: 989605449841 with 453561845331 (software version 1.0) Recall Number Z-0596-2016 REASON Color Flow direction is displayed incorrectly in Lumify 1.0. The system displayed Color Flow direction does not correctly represent the annotated Color Bar or...Read More

Company:Natus Neurology DBA Excel Tech., Ltd. (XLTEK) Date of Enforcement Report 1/132016 Class lI: PRODUCT Natus Quantum System with NeuroWorks Software. Catalog /Part Numbers: 013926. The Natus Quantum Amplifier is intended to be used as an electroencephalograph: to acquire, display, store and archive electrophysiological signals. The amplifier should be used in conjunction with Natus NeuroWorks...Read More

Company: Elekta, Inc. Date of Enforcement Report 1/13/2016 Class lI: PRODUCT Oncentra External Beam – VMAT – Radiation therapy planning system Product Usage: The Oncentra system is a radiation treatment planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer. Recall Number Z-0604-2016 REASON When...Read More