Class I Recall of Physio-Control Recalls LIFEPAK15 Monitor and Defibrillator

PUBLISHED: Feb 13, 2017
Source: Food and Drug Administration

Physio-Control is recalling the LIFEPAK Monitor/Defibrillator due to an electrical problem which may prevent the device from delivering the electrical shock needed to revive a patient in cardiac arrest. If the electrical shock is not delivered, the monitor will indicate “Abnormal Energy Delivery” on the display. A delay in delivering this therapy could result in serious patient injury such as permanent organ damage, brain injury, or death.

Recalled Product:

  • The LIFEPAK 15 Monitor/Defibrillator (LP15)
  • Serial Numbers: See full list in recall notice, link below
  • Distribution Dates: September 13, 2014, to July 4, 2016
  • Manufacturing Dates: September 3, 2014 to June 30, 2016
  • Devices Recalled in the U.S.: 139 nationwide

On January 12, 2017, Physio-Control sent an “Urgent Medical Device Correction” letter to all affected customers. The letter asked customers to:

  • Review the safety notice and ensure appropriate staff is aware of the notice.
  • Follow the instructions on the “Confirmation Sheet” for each serial number listed in the facility’s possession, and return the completed Confirmation Sheet to Physio-Control.
  • Perform the “User Test” every day, as instructed in the LIFEPAK 15 Operating Instructions, page 10-4. If the device fails the “User Test”, as described in the notice, contact Physio-Control immediately to arrange for correction of the device.
  • Continue to perform the User Test as outlined in the Daily Operator’s Checklist within the LIFEPAK 15 Operating Instructions.

See the recall notice for additional information.

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