The FDA issued a recall yesterday for the Defibtech RMU-2000 ARM XR Chest Compression Device due to a risk that the device may stop delivering compressions.
The recall was triggered after the company discovered a problem with the device's motor that may cause it to stop delivering compressions. This may cause serious adverse health consequences, like patient injuries, delay of therapy and death, due to a period of time without compressions to circulate oxygen throughout the body. The company reported one injury and one death thus far.
The FDA identified the recall as the "most serious type," the device may cause serious injury or death if patients continue to use it without following the updated instructions. The FDA instructed medical professionals to stop using the device and published a list of the affected serial numbers.
On July 12, 2024, Defibtech sent all affected customers an Urgent Medical Device Safety Removal letter recommending the identification and quarantine of affected units until the company can arrange a product return. According to the company, devices will be refunded, repaired, or replaced at no cost.
