The FDA has announced an urgent recall of the Defibtech RMU-2000 ARM XR Chest Compression Device due to a motor issue that could render the device inoperable. Defibtech, LLC, initiated the recall on July 12, 2024.
Defibtech issued the recall after reports of one injury and one fatality linked to use of their RMU-2000 ARM XR Chest Compression Device. The company identified the serial numbers of the impacted devices and sent an Urgent Medical Device Safety Removal letter to all relevant customers, asking them to cease use of and remove access to the device.
According to the company, a motor malfunction could cause the RMU-2000 ARM XR Chest Compression Device to stop compressions during CPR. For patients who have stopped breathing or are experiencing cardiac arrest, a breakdown of the machine could interrupt critical compressions, causing serious injury or even death as oxygen circulation is further compromised.
The Unique Device Identifier (UDI)/Model for the RMU-2000 ARM XR Chest Compression Device is 00815098020812 and 10815098020819. The FDA alert includes a list of over 200 impacted serial numbers. Defibtech will contact all impacted customers to arrange for a return or replacement of the faulty product. They will offer full refunds when appropriate.
Defibtech asks customers that may have purchased the product for another party or transferred ownership to pass along their recall letter. Alternately, customers can provide Defibtech with the new owner’s contact information, and the company will reach out to them directly.
Customers can reach Defibtech, LLC, from 7:30 a.m. to 6:30 p.m. EST at 1-877-453-4507 with any questions they may have about the recall.
If you or a family member have experienced an adverse health outcome or injury after using a defective medical device, a TruLaw attorney can help you pursue just compensation for your pain and suffering. Our team will investigate your case and fight aggressively to ensure the liable party is held responsible. To get started, contact us or take our free Instant Case Evaluation ℠.