The Food & Drug Administration has issued a Class I recall for LIFEPAK 1000 defribillators, distributed by Physio-Control Inc., one of the nation’s largest suppliers of defibrillators to hospitals, nursing homes, and first responders. According to Physio-Control’s website, the LIFEPAK 1000 is a portable Automated External Defibrillator (AED) designed for use by first responders on adults, children and even infants. The AED retails anywhere from $1400-$3100. AEDs are available to the public, but only with a prescription from a physician. It is also strongly advised that they only be operated by persons with formal training in CPR and AED usage.
Physio-Control voluntarily recalled the LIFEPAK 1000 after reports that the device experienced sudden losses of power. Although the devices can be restarted, every second counts in a cardiac emergency.
Recall Details, obtained directly from FDA.gov:
- The LIFEPAK 1000 defibrillator
- Affected Product Part Numbers: 320371500XX
- Serial Numbers: There are 133,330 affected serial numbers. Search Affected Devices
- Distribution Dates: June 30, 2006 to December 23, 2016
- Manufacturing Dates: June 30, 2006 to December 20, 2016
- Devices Recalled in the U.S.: 50,046 nationwide