Recall Z-2064-2011
Defibtech, LLC · initiated April 1, 2011
Product
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 be used and that therapy should not be delayed to determine the patients exact age or weight. The AED must also be used by or on the order of a physician. These AEDs are sold under the brand names Lifeline AED and ReviveR AED.
Codes / lots: Software version 2.004 or earlier S/N:'s To obtain a complete list , refer to firm's website: Defibtech.com 101000001 101001000 101001001 101001002 101001003 101001004 101001005 101001006 101001007 101001008 101001009 101001010 101001011 101001012 101001013 101001014 101001015 101001016 101001017 101001018 101001019 101001020 101001021 101001022 101001023 101001024 101001025 101001026 101001028 101001029 101001030 101001031 101001032 101001033 101001034 101001035 101001036 101001037 101001038 101001039 101001040 101001041 101001042 101001043 101001044 101001045 101001046 101001047 101001048 101001049 101001052 101001053 101001055 101001056 101001058 101001059 101001060 101001061 101001062 101001063 101001064 101001065 101001066 101001067 101001068 101001069 101001070 101001071 101001072 101001073 101001074 101001075 101001076 101001077 101001078 101001079 101001080 101001081 101001082 101001083 101001084 101001085 101001086 101001087 101001088 101001089 101001090 101001091 101001092 101001095 101001096 101001097 101001098 101001099 101001100 101001101 101001102 101001104 101001105 101001106 101001107 101001108 101001109 101001110 101001111 101001112 101001113 101001114 101001115…
Reason for recall
Software with version 2.004 software or earlier may cause an affected AED to cancel shock during the charging process
FDA-determined cause: Software design (manufacturing process)
Action taken
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 and contact information to fa@defibtech.com or call Defibtech directly at 1-877-453-4507 or 1-203-453-4501 and Defibtech will inform them if their unit is affected. 3) If their AED is affected, confirm receipt of this notification with Defibtech as soon as possible by website and/or confirmation card. Complete and return the confirmation form via fax to 1-203-738-1072. Note: "it is very important for you to contact us either through the Defibtech website or return this card to confirm that you have received this notice. This information will expedite the process of upgrading your AEDs." If your DDU-100 series AED serial number DOES NOT fall within the listed range, your AED is not affected by this recall. A letter was also sent to the distributors and direct accounts that have received the affected product by first class mail with a prepaid, return written acknowledgement card. The field action consists of a software change to the AED. All affected AEDs operating with software version 2.004 or earlier are to remain in the field and in service throughout the field action process. Upon receipt of contact information from affected customers, Defibtech will send an upgrade kit to customers consisting of a software data card, instructions on how to perform the upgrade, and a pre-paid upgrade confirmation postcard that must be returned to Defibtech upon completion
Details
- Recall number
- Z-2064-2011
- Initiated
- April 1, 2011
- Posted by FDA
- May 16, 2011
- Terminated
- March 30, 2021
- Product code
- MKJ – Automated External Defibrillators (Non-Wearable)
- 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, MALAYSIA, MEXICO, NETHERLANDS, NORWAY, PHILIPPINES, POLAND, PORTUGAL, SAUDI ARABIA, SINGAPORE…
- Recalling firm
- Defibtech, LLC, Guilford, CT