U.S. Food and Drug Administration Product Recall Alert!
Chest Compression Device Recall: Defibtech, LLC, Removes RMU-2000 ARM XR Chest Compression Device due to Risk of Device Stopping
The Office of Developmental Programs (ODP) is sharing this important announcement from the U.S. Food and Drug Administration (FDA) about the recall of Defibtech, LLC, RMU-2000 ARM XR Chest Compression Devices due to a problem with the device’s motor that may cause it to stop compressions.
The use of the affected product may cause serious adverse health consequences, including
- patient injuries;
- delay of therapy;
- death due to a period of time without compressions to circulate oxygen throughout the body.
This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without following the updated instructions.
Affected Product
- RMU-2000 Chest Compression Module
- Product Name: RMU-2000 ARM XR Chest Compression Device
- Unique Device Identifier (UDI)/: UDI-DI: 00815098020812, 10815098020819
- Serial Numbers: See full list.
What to Do
Do not use affected Defibtech RMU-2000 ARM XR Chest Compression Devices (identified by
serial numbers).
On July 12, 2024, Defibtech, LLC, sent all affected customers an Urgent Medical Device Safety Removal letter recommending the following actions:
- Identify and quarantine affected units.
- If devices were transferred or distributed further, please ensure the recipients are aware of this notice or provide Defibtech with contact information.
Customers will be contacted by Defibtech to arrange for product return and devices will be refunded, repaired, or replaced at no cost.
Reason for Recall
Defibtech, LLC, is recalling RMU-2000 ARM XR Chest Compression Devices due to a problem with the device’s motor that may cause it to stop compressions.
The use of affected product may cause serious adverse health consequences, including patient injuries, delay of therapy and death due to a period of time without compressions to circulate oxygen throughout the body. There has been one reported injury and one report of death.
Device Use
The RMU-2000 ARM XR Chest Compression Device is used to provide chest compressions on adults whose hearts suddenly stop and are not circulating blood throughout the body.
Contact Information
Customers in the U.S. with questions about this recall should contact Defibtech Customer Support: 1-877-453-4507, 7:30AM - 6PM Eastern.
