Recall Z-2543-2024— Defibtech, LLC
Class I · Ongoing
Class I FDA medical device recall by Defibtech, LLC, initiated 2024-07-12. It names one FDA 510(k) clearance: K211289. Product: RMU-2000 Automated Chest Compression Device. 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..
- Recalling firm
- Defibtech, LLC
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2024-07-12
- Firm location
- Guilford, CT, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
RMU-2000 Automated Chest Compression Device
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.