6 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.

• LIFEPAK 1000 Defibrillators May Shut Down During Use, FDA Warns

  March 9, 2017

  Russell Maas

  Problems with the LIFEPAK 1000 defibrillator could cause a failure to deliver life-saving shocks, resulting in an FDA Class I recall classification.

• External Defibrillator Problems May Lead to Stricter FDA Requirements

  January 24, 2011

  Staff Writers

  Federal regulators are proposing more stringent standards for the manufacture of external heart defibrillators, including a stricter approval process, to...

• FDA Considers New Rules to Address External Defibrillator Problems

  November 16, 2010

  Staff Writers

  Federal regulators are warning medical device manufacturers that if they do not take actions to prevent the release of defective...

• Lifepak 20 Defibrillator Recall: Power Supply May Fail

  July 6, 2010

  Staff Writers

  About 43,000 Lifepak 20 and Lifepak 20e defibrillators have been recalled because the power supply could fail; a malfunction that...

• External Defibrillator Recall: Medtronic Physio-Control LIFEPAK CR Plus

  September 15, 2008

  AboutLawsuits

  Physio-Control Inc., a wholly-owned subsidiary of Medtronic Inc., has issued a nationwide recall for a limited number of LIFEPAK CR...