ReviveR AED semiautomatic external defibrillator used with the DBP-2800 Battery Pack. Manufactured by Defibtech, LLC. Seymour, CT 06483. The DBP-2800 battery pack is an accessory to the AED and does not have its own intended use. The AED is intended for use on victims of sudden cardiac arrest when the patient is unconscious, unresponsive and not breathing.
This recall has been terminated (originally issued June 10, 2010).
- Company
- Defibtech Llc
- Recall Initiated
- May 21, 2010
- Posted
- June 10, 2010
- Terminated
- September 29, 2020
- Recall Number
- Z-1782-2010
- Firm Location
- Seymour, CT
- Official Source
- View on FDA website ↗
Reason for Recall
The AED when used with an affected battery pack, may falsely detect an error condition, cancel charge and not provide therapy
Distribution
Worldwide Distribution -- United States, Canada, Australia, Jordan, Spain, Israel, UK, Poland, Italy, Netherlands, Malaysia and Ireland.
Lot / Code Info
Serial Numbers range from 202001005 through 202005916 and 206001001 through 206009871.
Root Cause
Device Design
Action Taken
Defibtech, LLC issued an "Urgent Medical Device Safety Information and Correction" notification dated May 20, 2010 by email and hard copy via US Mail. The notification instructed Consignees on proper identification of affected product and steps to take for product replacement. For further information, contact your distributor or Defibtech Technical Support at techsupport@defibtech.com or call 1-877-453-4507 or 1-203-453-4507, 8:30 AM to 5:00 PM Monday - Friday, EST.