LIFEPAK 1000 Defibrillators May Shut Down During Use, FDA Warns
Problems with the LIFEPAK 1000 defibrillator could cause a failure to deliver life-saving shocks, resulting in an FDA Class I recall classification.…
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Problems with the LIFEPAK 1000 defibrillator could cause a failure to deliver life-saving shocks, resulting in an FDA Class I recall classification.…
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. …
About 43,000 Lifepak 20 and Lifepak 20e defibrillators have been recalled because the power supply could fail; a malfunction that may have led to the death of at least one patient. …
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.…