Recall Z-2543-2024 ยท DRM Compressor, Cardiac, External
Defibtech, LLC
RMU-2000 Automated Chest Compression Device
| Date | Aug 14, 2024 (initiated Jul 12, 2024) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Process control |
| Action | On July 12, 2024, the firm notified affected users via Urgent Medical Device Safety Removal letters. Affected units (as identified by serial number) should be quarantined by the customer. Defibtech will contact customers to arrange for the return of the product. Customers' devices will be refunded, repaired, or replaced at no cost to them. Customers who have further transferred the device to a downstream account must notify those accounts of this notice or provide Defibtech with the contact information for those sub-accounts. Defibtech Customer Support: 1-877-453-4507, 7:30AM - 6PM Eastern, |
| Quantity | 174 US, 37 OUS |
| Distribution | Domestic distribution to CT, FL, NJ, SC, TN. Foreign distribution to Japan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K211289 | RMU-2000 Automated Chest Compression System Defibtech, LLC, Nov 9, 2021 |