News | February 22, 2010

FDA Allows Defibrillator Maker to Resume Shipments

February 22, 2010 – The FDA said Physio?Control Inc. has improved the quality of its external defibrillators and may resume unrestricted worldwide shipments.

In May 2008, Physio?Control signed a consent decree with the FDA to address issues the agency raised during inspections of the company’s quality system. Under the terms of this agreement, Physio?Control was permitted to ship a limited number of products to emergency care providers to meet public health and safety needs until quality system improvements were completed.

During the past two years, Physio?Control received FDA 510(k) clearance of the LIFEPAK 15 monitor/defibrillator, the LIFEPAK 20e defibrillator/monitor and the LIFENET System Version 4.1, the latest update of its Web?based platform for capturing and sharing emergent STEMI patient data. The company also introduced a new battery?operated version of the LUCAS Chest Compression System, a portable, easy?to?use device that delivers automated chest compressions to improve blood flow in victims of cardiac arrest.

For more information:

Related Content

Zoll Canada Equipping Province of Québec Paramedic Services with X Series Monitor/Defibrillators
News | Defibrillator Monitors | October 16, 2017
October 16, 2017 — Zoll Canada, a subsidiary of Zoll Medical Corp., announced it has won the tender to equip all ambu
Physio-Control Launches HeartSine samaritan PAD 360P Automated External Defibrillator in United States
Technology | Defibrillator Monitors | April 24, 2017
Physio-Control announced April 19 that the company’s HeartSine samaritan PAD 360P (SAM 360P) fully automatic external...
AEDs, automated external defibrillators, requirements, U.S. schools, JACC study
News | Defibrillator Monitors | March 30, 2017
Automated external defibrillators (AEDs) are associated with increased survival of sudden cardiac arrest when installed...
Philips, FDA, class I recall, HeartStart MRx Monitor/Defibrillator
News | Defibrillator Monitors | March 28, 2017
Philips and the U.S. Food and Drug Administration (FDA) announced the company has initiated a recall of its HeartStart...
Zoll, Hospital Wearable Defibrillator, HWD, FDA premarket approval
Technology | Defibrillator Monitors | March 10, 2017
Zoll Medical Corp. announced that the company’s Hospital Wearable Defibrillator (HWD) has been granted premarket...
Zoll LifeVest wearable defibrillator, WEARIT-II Registry results, CardioStim EuroPace 2016
News | Defibrillator Monitors | June 21, 2016
Zoll Medical Corp. announced that patients experience a high one-year survival rate following use of the LifeVest...
defibrillator-monitors, defibrillator monitor

Physio-Control's LifePAK15

Feature | Defibrillator Monitors | February 03, 2014 | Dave Fornell
For U.S. hospitals and emergency medical services (EMS) looking to upgrade their aging defibrillator-monitors, new...
Overlay Init