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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Device
Medical Devices/Monitoring Devices

Defibtech, LLC: RMU-2000 Automated Chest Compression Device Recalled for Motor Failure

Agency Publication Date: August 14, 2024
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Summary

Defibtech, LLC has recalled 174 RMU-2000 Automated Chest Compression Devices in the United States (and 37 internationally) because a problem with the device's motor may cause it to stop performing compressions during use. This failure can cause a critical delay in life-saving therapy during a cardiac event, which could lead to serious patient injury or death. The affected devices were distributed in Connecticut, Florida, New Jersey, South Carolina, and Tennessee between July 12, 2024, and the current ongoing recall period.

Risk

The device's motor can malfunction and cease mechanical chest compressions abruptly. If the device fails to operate during a resuscitation attempt, the patient will not receive necessary circulatory support, potentially leading to permanent brain damage or death due to the interruption of therapy.

What You Should Do

  1. Locate your RMU-2000 Automated Chest Compression Device and check the serial number and UDI-DI against the affected list. Affected UDI-DIs are 00815098020812 and 10815098020819.
  2. Check if your device's serial number is among the 211 affected units, which include numbers such as 502001000, 502000281, 502000979, 502000960, 502000985, and 502000988 (see the full list of over 200 serial numbers provided in the product details).
  3. If your device is affected, immediately contact Defibtech, LLC or your healthcare provider to discuss the status of the device and obtain further technical instructions.
  4. Contact Defibtech, LLC at their Guilford, Connecticut headquarters at 741 Boston Post Rd, Suite 201, or through their customer service channels to arrange for a potential remedy or device evaluation.
  5. For additional information or to report problems, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer instructions for device failure risk

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: RMU-2000 Automated Chest Compression Device
Model / REF:
RMU-2000
UPC Codes:
00815098020812
10815098020819
Lot Numbers (216):
502001000
502000281
502000979
502000960
502000985
502000988
502000264
502000201
502000973
502000249
502000248
502000205
502000216
502000217
502000275
502000204
502000234
502000267
502000270
502000237
502000232
502000227
502000907
502000908
502000980
502000987
502000078
502000074
502000064
502000072
502000224
502000235
502000223
502000225
502000231
502000222
502000245
502000246
502000932
502000220
502000938
502000934
502000945
502000946
502000922
502000958
502000927
502000944
502000942
502000236

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94960
Status: Active
Manufacturer: Defibtech, LLC
Sold By: Defibtech authorized distributors; medical supply channels
Manufactured In: United States
Units Affected: 174 US, 37 OUS
Distributed To: Connecticut, Florida, New Jersey, South Carolina, Tennessee

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.