PlainRecalls
FDA Devices Critical Class I Ongoing

RMU-2000 Automated Chest Compression Device

Reported: August 21, 2024 Initiated: July 12, 2024 #Z-2543-2024

Product Description

RMU-2000 Automated Chest Compression Device

Reason for Recall

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.

Details

Recalling Firm
Defibtech, LLC
Units Affected
174 US, 37 OUS
Distribution
Domestic distribution to CT, FL, NJ, SC, TN. Foreign distribution to Japan
Location
Guilford, CT

Frequently Asked Questions

What product was recalled?
RMU-2000 Automated Chest Compression Device. Recalled by Defibtech, LLC. Units affected: 174 US, 37 OUS.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on August 21, 2024. Severity: Critical. Recall number: Z-2543-2024.