The Recall Desk
SevereFDA (Devices)·Z-2543-2024·Announced 2024-08-21

RMU-2000 Automated Chest Compression Device Recalled Due to Motor Failure

Defibtech is recalling the RMU-2000 Automated Chest Compression Device because a motor defect may cause the device to stop delivering compressions, potentially delaying critical therapy and resulting in patient injury or death.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA classified this as a Class I recall, which mandates a minimum Severe rating. The motor defect directly prevents the device from delivering critical cardiac compressions, which could interrupt emergency therapy and potentially result in patient injury or death.

Plain-English summary

Defibtech, LLC is recalling the RMU-2000 Automated Chest Compression Device. This medical device is designed to deliver automated chest compressions in cardiac resuscitation scenarios. Approximately 174 units were distributed across the United States (Connecticut, Florida, New Jersey, South Carolina, and Tennessee), and 37 units were distributed internationally to Japan.

A defect in the device's motor may cause it to stop delivering compressions. If the device fails during operation, therapy delivery would be interrupted, potentially delaying critical cardiac intervention. The FDA warns that this failure could result in patient injury or death.

Affected units can be identified using the UDI-DI codes (00815098020812, 10815098020819) and the serial numbers provided in the recall notice. Users and healthcare facilities with affected devices should contact Defibtech for further guidance regarding this recall.

The recalled product

Product
RMU-2000 Automated Chest Compression Device
Manufacturer
Defibtech, LLC
Hazard
  • motor-failure
  • therapy-interruption

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • UDI-DI: 00815098020812

Distribution

Distributed in 5 states:

  • CT
  • FL
  • NJ
  • SC
  • TN