FDA recall Z-2543-2024

Product

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.

Distribution

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

Key facts

Status

Ongoing

Initiation date

2024-07-12

Report date

2024-08-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Guilford, CT, United States

Primary source

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