The Federal Drug Administration (FDA) has issued a warning that a defibrillator made by Phillips may have a key flaw in the device, the agency announced via press release.

The devices are certain HeartStart automated external defibrillators (AED) and they may not be capable of delivering the necessary shock in a cardiac emergency. The devices have been recalled, but the FDA issued the safety communication for anyone who may own or use one.

"The FDA advises keeping all recalled HeartStart AEDs in service until you obtain a replacement from Philips Healthcare or another AED manufacturer, even if the device indicates it has detected an error during a self-test," Steve Silverman, director of the Office of Compliance in the FDA's Center for Devices and Radiological Health, said in the release. "Despite current manufacturing and performance problems, the FDA considers the benefits of attempting to use an AED in a cardiac arrest emergency greater than the risk of not attempting to use the defibrillator."

The devices, named HeartStart FRx, HeartStart HS1 Home, and HeartStart HS1 OnSite, were manufactured and distributed between 2005 and 2012 to consumers and first responders. Anyone who owns such a device has been encouraged to contact Phillips Healthcare immediately for a replacement device.

The AEDs were made by Phillips Medical Systems, a division of Phillips Healthcare, and the recall on the certain devices began in Sept. 2012.

An AED is meant to reset a person's irregular heart rhythm to normal in the emergency event of a cardiac arrest. If the electrical shock is not working properly, there is no way the device can serve its intended purpose.

The recall affected and estimated 700,000 devices, but, going forward, the FDA will monitor the manufacturing of these AED devices to ensure quality products. In March 2013, the FDA issued an order that, if approved, would require all AED makers to get their devices OK'd before hitting the market.

AEDs are known to save lives when they work properly, so the FDA's proposed order would attempt to ensure each device continues to do so.