Recall Z-2064-2011 ยท MKJ Automated External Defibrillators (Non-Wearable)
Defibtech, LLC
Defibtech Lifeline AED and ReviveR AED, Model: DDU-100 Series AEDs Software version 2.004 or earlier The product under correction is the DDU-100 AED. The AED is indicated for use on victims of sudden cardiac arrest (SCA) when the patient is unconscious, unresponsive and not breathing. The indications for use also state that for patients under 8 years old, child/ infant electrode pads are to b
| Date | May 16, 2011 (initiated Apr 1, 2011) |
| Status | Terminated |
| Reason | Software with version 2.004 software or earlier may cause an affected AED to cancel shock during the charging process |
| Root cause | Software design (manufacturing process) |
| Action | The firm, Defibtech, sent an "URGENT MEDICAL DEVICE SAFETY INFORMATION AND CORRECTION" letter dated March 11, 2011 to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to do the following: 1) Remove the pads from the storage pouch on the back of their DDU-100 series AED and inspect the 9-digit serial number label. 2)Carefully note the 9-digit serial number on the back of the AED, then visit the Defibtech website at www.defibtech.com/fa11 and enter their serial number to determine if their AED is affected; email their serial number |
| Quantity | 91, 472 units |
| Distribution | Worldwide distribution: USA (nationwide) and countries including: AUSTRALIA, AUSTRIA , BAHRAIN, BRAZIL, CANADA, CHILE, CHINA , CYPRUS, CZECH REPUBLIC, EGYPT, EL SALVADOR, FRANCE, GERMANY, GREECE, HONG KONG, HUNGARY, INDIA, INDONESIA, IRELAND, ISRAEL, ITALY, JORDAN, KOREA, REPUBLIC OF LITHUANIA, MALA |
| FDA record | Open on fda.gov |