FDA designates recall of automated chest compression device as class I

Fact checked byErik Swain

Key takeaways:

The FDA designated Defibtech’s recall of its automated continuous chest compression device as class I, the most serious type.
An issue with the device’s motor may cause it to halt compressions during use.

Defibtech has issued a recall of its automated continuous chest compression device due to risk for the device to halt compressions during use.

The FDA has identified the recall of this device (RMU-2000 ARM XR Chest Compression Devices) as class I recall, the most serious type of recall, as use of the device may cause injury or death.

Due to an issue with the device’s motor causing it to stop compressions mid-use, the product may cause serious patient injury, delay of therapy or death due to a period of time without compressions, according to the FDA press release.

There has been one reported injury and one death due to the malfunction, according to the release.

Please see the FDA release for the full list of recalled serial numbers.

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FDA designates recall of automated chest compression device as class I

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