Cardiac Science Recall February 2012

[defibyourclub]

The (TGA) Therapeutic Goods Administration in Australia have confirmed that Cardiac Science have issued a recall in February 2012 and there area significant number of units affected in Australia. Clubs who have purchased a Cardiac Science Defibrillator through "Defib your club" should check their unit and if it is affected it needs to be returned to the manufacturing plant in the united States.

Reason for Recall
The affected Automated External Defibrillators (AEDs) contains a circuit board manufactured with a component that may fail unexpectedly due to a supplier manufacturing defect. If the component were to fail during a rescue attempt, the AED may not deliver defibrillation therapy.

Action
Cardiac Science sent an "URGENT-Voluntary Medical Device Recall" letter dated January 13, 2012 to all affected customers. The letter described the product, problem, and actions to be taken by the customers. Customers are advised to immediately return the device to the manufacturing location for repair. The affected devices will receive a hardware correction, and the same serial number device returned to the consignee in most cases. Customers in the US can call 1-888-402-2484 and customers outside the US can call 1-425-402-2482 or email at aed210@cardiacscience.com to arrange delivery of the shipping materials. Customers can also visit www.cardiacscience.com/aed210 for more information about AEDs affected by this recall.