FDA Issues Safety Notice on Recalled Heart Defibrillators
The FDA issued a safety notice for automated external defibrillator (AED) devices made by Philips Medical Systems and sold under the name of HeartStart. This includes approximately 700,000 devices including HeartStart FRx, HeartStart HS1 Home, and HeartStart HS1 OnSite.
These devices were previously recalled due to an inability to deliver the proper defibrillator shock in a cardiac emergency. The FDA notice offers recommendations to better inspect and monitor the readiness of these devices. It also advises users that the benefits of using a potentially defective defibrillator during an emergency are worth the risks of not using one at all. More information regarding the safety notice can be found on the FDA’s website.
If you or someone you care about has suffered a serious injury associated with the use of an AED device, contact us. Our product liability attorneys have litigated thousands of product liability claims against pharmaceutical companies and medical device manufacturers and can advise you of your legal rights and options.