26 results

• Stryker Lifepak 15 Defibrillator Warning: Device May “Lock Up” While Delivering Life-Saving Shocks

  February 4, 2019

  Russell Maas

  Stryker is warning of potential problems with its Lifepak-15 defibrillators that could lead to them locking up, and has been linked to at least six deaths.

• Wearable Cardioverter–Defibrillators Failed To Reduce Risk Of Death For Recent Heart Attack Patients: Study

  October 4, 2018

  Irvin Jackson

  A new study suggests that wearble heart defibrillators do not increase the risk of survival in patients who recently suffered a heart attack.

• Zoll LifeVest 4000 Wearable Cardioverter Defibrillator Recall Issued Over Device Failures

  January 18, 2018

  Russell Maas

  Tens of thousands of Zoll LifeVest 4000 wearable defibrillators are being recalled due to an error which can prevent them from giving life-saving shocks.

• FDA To Require More Stringent Approval Process for Automated External Defibrillators

  January 29, 2015

  Irvin Jackson

  The FDA has issued new rules calling for stricter approval processes for automated external defibrillators following numerous recalls.

• Medical Device Recalls Up 97% Since 2002: FDA Report

  March 25, 2014

  Irvin Jackson

  A new report shows medical device recalls up 97% since 2003, which the FDA says is a sign that efforts to get bad devices off the market are working.

• HeartSine Defibrillator Problems Not Addressed: FDA

  February 14, 2014

  Martha Garcia

  The FDA accuses a company of failing to properly address problems linked to defective automated external defibrillators that are linked to several deaths.

• FDA Warns of Problems with Recalled Phillips HeartStart Defibrillators

  December 4, 2013

  Russell Maas

  A new warning about Phillips HeartStart defibrillators recalled a year ago indicates the devices could fail to give life-saving electrical shocks.

• HeartSine Issues Fix For Samaritan Public Defibrillators

  September 17, 2013

  Martha Garcia

  HeartSine has reissued a recall statement for Samaritan Public Access Defibrillators, adding new information about an upgrade kit to help with battery failures.

• Heart Defibrillator Failures Lead FDA to Propose Stronger AED Standards

  March 25, 2013

  Martha Garcia

  The FDA has proposed new guidelines that are aimed at improving the standards for automated external defibrillators (AEDs), which have...

• Power Problems Lead to Heartsine Defibrillator Recall

  November 20, 2012

  Irvin Jackson

  Federal health regulators are warning about problems with HeartSine Samaritan Public Access Defibrillators (PAD), which may cause them to turn...