10 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Iii
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Achieva 1.5T, Model No. 781178, 781196, 781296
FDA Enforcement
Class III
·Ongoing·Philips North America·January 31, 2024
Ingenia Ambition X, Model No. 782109
FDA Enforcement
Class III
·Ongoing·Philips North America·January 31, 2024
Achieva 1.5T Conversion, Model No. 781283
FDA Enforcement
Class III
·Ongoing·Philips North America·January 31, 2024
Intera 1.5T, Model No. 781195
FDA Enforcement
Class III
·Ongoing·Philips North America·January 31, 2024
Achieva 3.0T, Model No. 781177
FDA Enforcement
Class III
·Ongoing·Philips North America·January 31, 2024
SmartPath to dStream for 1.5T, Model No. 781260, 782112
FDA Enforcement
Class III
·Ongoing·Philips North America·January 31, 2024
Philips IntelliBridge System configured with a regional setting which uses a comma for a decimal separator: 866417 IntelliBridge System C.01 (or later) 866418 IntelliBridge System C.01 upgrade (or later) Product Usage: The IntelliBridge System is indicated for use in data collection and clinical information management either directly or through networks with independent bedside devices. The system is not intended for monitoring purposes, nor is the system intended to control any of the clinical devices (independent bedside devices / information systems) it is connected to. The IntelliBridge solution is intended for use in professional healthcare facilities by trained healthcare professionals.
FDA Enforcement
Class III
·Terminated·Philips North America, LLC·June 19, 2019
Philips Patient Information Center iX configured with a regional setting which uses a comma for a decimal separator: 866389 Patient Information Center iX B.01 (or later); 866390 Patient Information Center iX B.01 upgrade (or later) Product Usage: The intended use of the Information Center Software is to display physiologic waves, parameters, and trends, format data for strip chart recordings and printed reports, and provide the secondary annunciation of alarms from other networked medical devices at a centralized location. The Information Center Software provides for the retrospective review of alarms, physiologic waves and parameters from its database. An additional intended use of the Information Center Software is to provide primary annunciation of alarms and configuration and control access for networked telemetry monitors
FDA Enforcement
Class III
·Terminated·Philips North America, LLC·June 19, 2019
HeartStart XL+ Defibrillator/Monitor The HeartStart XL+ is intended for use in a hospital setting by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced life support, or defibrillation. It must be used by or on the order of a physician. When operating as a semi-automatic external defibrillator in AED Mode, the HeartStart XL+ is suitable for use by medical personnel trained in basic life support that includes use of an AED. When operating in Monitor, Manual Defib, or Pacer Mode, the HeartStart XL+ is suitable for use by healthcare professionals trained in advanced life support.
FDA Enforcement
Class III
·Terminated·Philips Electronics North America Corporation·March 21, 2018
Philips SureSigns VSi / SureSigns VS2+ vital signs monitor used in healthcare environments and transport within a facility.
FDA Enforcement
Class III
·Terminated·Philips Electronics North America Corporation·December 27, 2017