DDU-100 Lifeline Automated External Defibrillator (AED)-Indicated for use on victims of sudden cardiac arrest
Reported: April 5, 2023 Initiated: February 14, 2023 #Z-1312-2023
Product Description
DDU-100 Lifeline Automated External Defibrillator (AED)-Indicated for use on victims of sudden cardiac arrest
Reason for Recall
A component of a sub-assembly used in the affected AEDs had not undergone durability and reliability testing, and if a malfunction occurs, therefore the device could fail to deliver therapy.
Details
- Recalling Firm
- Defibtech, LLC
- Units Affected
- 29 units
- Distribution
- US Nationwide distribution.
- Location
- Guilford, CT
Frequently Asked Questions
What product was recalled? ▼
DDU-100 Lifeline Automated External Defibrillator (AED)-Indicated for use on victims of sudden cardiac arrest. Recalled by Defibtech, LLC. Units affected: 29 units.
Why was this product recalled? ▼
A component of a sub-assembly used in the affected AEDs had not undergone durability and reliability testing, and if a malfunction occurs, therefore the device could fail to deliver therapy.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 5, 2023. Severity: Moderate. Recall number: Z-1312-2023.
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