Defibtech, LLC recalls RMU-2000 Automated Chest Compression Device

Recall date

July 12, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2543-2024

FDA classification

Class I

Brand / firm

Defibtech, LLC

Sold / distributed

Domestic distribution to CT, FL, NJ, SC, TN. Foreign distribution to Japan

Why it was recalled

Problem in the device's motor may cause the device to stop compressions. This may lead to a delay in therapy if the device fails to operate, and could lead to patient injury or death.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

RMU-2000 Automated Chest Compression Device