Defibtech, LLC: Device Recall

Recall #Z-2543-2024 · 07/12/2024

Class I: Dangerous

Recall Details

Recall Number: Z-2543-2024
Classification: Class I
Product Type: Device
Recalling Firm: Defibtech, LLC
Status: Ongoing
Date Initiated: 07/12/2024
Location: Guilford, CT, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 174 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.

Product Description

RMU-2000 Automated Chest Compression Device

Distribution Pattern

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

Other Recalls by Defibtech, LLC

Class II: Risk 03/18/2025

It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Medical Devices Ordinance (MedDO) states that product information (labelling and instructions for use) should be provided in all three official languages of Switzerland (German, French, and Italian).
Class II: Risk 03/18/2025

It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Medical Devices Ordinance (MedDO) states that product information (labelling and instructions for use) should be provided in all three official languages of Switzerland (German, French, and Italian).
Class II: Risk 03/18/2025

It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Medical Devices Ordinance (MedDO) states that product information (labelling and instructions for use) should be provided in all three official languages of Switzerland (German, French, and Italian).
Class II: Risk 03/18/2025

It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Medical Devices Ordinance (MedDO) states that product information (labelling and instructions for use) should be provided in all three official languages of Switzerland (German, French, and Italian).
Class II: Risk 03/18/2025

It was noticed there was no Italian translation included for the AED. Article 16 of the Swiss Medical Devices Ordinance (MedDO) states that product information (labelling and instructions for use) should be provided in all three official languages of Switzerland (German, French, and Italian).

View all recalls by Defibtech, LLC →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.