Recall Z-1782-2010 ยท MKJ Automated External Defibrillators (Non-Wearable)
Defibtech LLC
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.
| Date | Jun 10, 2010 (initiated May 21, 2010) |
| Status | Terminated |
| Reason | The AED when used with an affected battery pack, may falsely detect an error condition, cancel charge and not provide therapy |
| Root cause | Device Design |
| Action | 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. |
| Distribution | Worldwide Distribution -- United States, Canada, Australia, Jordan, Spain, Israel, UK, Poland, Italy, Netherlands, Malaysia and Ireland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K013896 | SENTRY SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR; EXTERNAL DEFIBRILLATION PADS (ELECTRODES) DDP-100; BATTERY PACK 1200MAH; BA Defibtech, LLC, Jun 19, 2002 |