Defibtech has voluntarily recalled 65,885 of its DDU-100 series semi-automatic external defibrillators (AEDs), sold under Lifeline and ReviveR AED brand names, after it realized some of these devices were shipped with 2.0044 software or earlier. The FDA has deemed this a Class I recall.
According to Guilford, Conn.-based Defibtech, while only some of the devices are affected, the recall is a preventive measure due to the fact that the earlier software versions could cause an affected AED to cancel shock and fail to provide therapy to patients.
The company said that the correction of these devices will seek to prevent two conditions:
- To prevent the AED from canceling charges in preparation for a shock. Defibtech said that the odds of this occurring in the affected AED is less than one in 400,000 chances per month; and
- To prevent the AED from canceling a charge in preparation for a shock in very high humidity. However, the company said the odds of an affected AED having this happen is less than one in 250,000 chances per month.
Defibtech said that it will provide customers with a free software upgrade to address the aforementioned issues.
“Because both of these conditions occur very rarely, it is recommended that customers keep their AEDs in service until they have performed the software upgrade,” the company noted. Additionally, instructions and recommendations will be mailed to affected customers.
Customers can go to the following website to determine whether a certain AED could be affected: http://www.defibtech.com/fa11
The FDA has determined this recall a Class I and has asked customers to report any adverse reaction to the agency’s MedWatch Program.