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Open, Classified

RMU-2000 Automated Chest Compression Device

FDA Recall Z-2543-2024 · Posted 2024-08-14

Recalling FirmDefibtech, LLC
Recall StatusOpen, Classified
Product CodeDRM
Date Initiated2024-07-12
Product Quantity174 US, 37 OUS

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.

Firm 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, Monday thru Friday.

Root Cause

Process control

Distribution Pattern

Domestic distribution to CT, FL, NJ, SC, TN. Foreign distribution to Japan

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K211289RMU-2000 Automated Chest Compression SystemDefibtech, LLC · 2021-11-09

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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