RMU-2000 Automated Chest Compression Device
FDA device recall Z-2543-2024 · posted 2024-08-14 · Open, Classified
Recall details
- Recalling firm
- Defibtech, LLC
- 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.
- Action taken
- 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, Monday thru Friday.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- DRM
- Quantity affected
- 174 US, 37 OUS
- Distribution
- Domestic distribution to CT, FL, NJ, SC, TN. Foreign distribution to Japan
- Date initiated
- 2024-07-12
- Date posted
- 2024-08-14
- Location
- Guilford, CT
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| RMU-2000 Automated Chest Compression System (K211289) | Defibtech, LLC | 2021-11-09 |