FDA announces Class 1 recall for chest compression devices

Editor's Note

The US Food and Drug Administration (FDA) has designated Defibtech, LLC’s recall of RMU-2000 ARM XR Chest Compression Devices as Class 1, the most severe category indicating serious risk of injury or death.

A motor issue could stop  compressions in adults whose hearts suddenly stop, according to the August 22 FDA report, which lists quarantine numbers for all affected devices.  

On July 12, 2024, Defibtech recommended customers identify and quarantine affected units, FDA reports. One injury and one death have been reported.