FDA-Device2024-08-21Class I

RMU-2000 Automated Chest Compression Device

Defibtech, LLC
Hazard

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.

Sold states
Domestic distribution to CT, FL, NJ, SC, TN. Foreign distribution to Japan
Affected count
174 US, 37 OUS
Manufactured in
741 Boston Post Rd, Suite 201, Guilford, CT, United States
Products
RMU-2000 Automated Chest Compression Device

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2543-2024

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