Lifeline AED DDU-100 semiautomatic external defibrillator used with the DBP-2800 Battery Pack, Manufactured by Defibtech
FDA device recall Z-1781-2010 · posted 2010-06-10 · Terminated
Recall details
- Recalling firm
- Defibtech LLC
- Reason for recall
- The AED when used with an affected battery pack, may falsely detect an error condition, cancel charge and not provide therapy
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- MKJ
- Distribution
- Worldwide Distribution -- United States, Canada, Australia, Jordan, Spain, Israel, UK, Poland, Italy, Netherlands, Malaysia and Ireland.
- Date initiated
- 2010-05-21
- Date posted
- 2010-06-10
- Date terminated
- 2020-09-29
- Location
- Seymour, CT
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SENTRY SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR; EXTERNAL DEFIBRILLATION PADS (ELECTRODES) DDP-100; BATTERY PACK 1200MAH; BA (K013896) | Defibtech, LLC | 2002-06-19 |