Company: Defibtech, LLC .
Date of Enforcement Report 4/29/2011
Class l:
Date Recall Initiated: March 14, 2011
PRODUCT
Model DDU-100 series with software version 2.004 or earlier, sold under the brand names Lifeline and ReviveR.
65,885 AEDs distributed in the United States are subject to this recall.
The 267 affected lots were distributed in February 2011. According to the company, all affected products have been accounted for and returned.
Defibtech will provide customers with a free software upgrade. Because the conditions that may lead to a canceled shock occur rarely, it is recommended that customers keep their AEDs in service during the software upgrade process. Full instructions and recommendations are being mailed to affected customers. Defibtech is responsible for contacting all end users unless a distributor has agreed to contact their accounts directly regarding this field correction.
REASON
AEDs using software version 2.004 or earlier may cause the device to cancel shock during the charging process. Failure to provide appropriate therapy may result in failure to resuscitate the patient.
RECALLING FIRM
Defibtech, LLC, Guilford, CT
FDA District: New England
