Federal regulators are proposing more stringent standards for the manufacture of external heart defibrillators, including a stricter approval process, to combat thousands of reports involving defibrillator malfunctions. …
Federal regulators are warning medical device manufacturers that if they do not take actions to prevent the release of defective defibrillators onto the market, they may face new, more stringent regulations over their construction in the near future. …
Physio-Control Inc., a wholly-owned subsidiary of Medtronic Inc., has issued a nationwide recall for a limited number of LIFEPAK CR Plus Automated External Defibrillators.…
