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March 16, 2017

Physio-Control Inc. Recalls LIFEPAK 1000 Defibrillator

Due to an electrical issue which may cause the device to shut down unexpectedly, Physio-Control has recalled the LIFEPAK 1000 defibrillator. This defibrillator is intended for use by medical professionals who are trained in CPR, and is used to deliver lifesaving electrical shocks to people with sudden cardiac arrest.

According to the recall notice, it was determined that wear and oxidation formation between the battery and device electrical contacts may cause power interruptions. This may prevent the device from delivering the electrical shock needed to revive a patient in cardiac arrest. A delay in delivering this therapy could result in serious patient injury such as permanent organ damage, brain injury or death.

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

Recalled Product:

  • 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

Physio-Control anticipates contacting customers in May 2017, to schedule a hardware device correction for the LIFEPAK 1000 devices, which includes modifying the power control circuit board of the device and placing dielectric lubrication on the battery and device contacts.

Health care professionals and consumers with questions are instructed to contact Physio Control at 1-866-231-1220 with any questions related to this recall.

Click here to read the full recall notice.

 

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