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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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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

Echonous Inc: Kosmos on iOS Ultrasound Systems Recalled for Software Measurement Bug

Agency Publication Date: July 10, 2024
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Summary

Echonous Inc. has recalled approximately 272 units of its Kosmos on iOS ultrasound software, models P007639 and P007944, due to a software bug. This defect causes measurements to become inaccurate after the data is exported to third-party software like PACS. This issue affects units with software versions 1.0, 2.1, and 2.2 that were distributed across 34 U.S. states and several international countries. Consumers should contact their healthcare provider or Echonous Inc. for guidance on addressing this software issue.

Risk

The software bug causes incorrect data to be exported to post-processing software, which can result in inaccurate medical measurements. This may lead to incorrect diagnoses or improper treatment plans for patients.

What You Should Do

  1. Check your ultrasound system for Model Numbers P007639 or P007944 and verify if you are using software versions 1.0, 2.1, or 2.2.
  2. Verify the UDI-DI on your device matches 09353278000717 or 09353278000762.
  3. Identify if you have exported data from these iOS-based systems to third-party PACS or other post-processing software for diagnostic measurements.
  4. Contact Echonous Inc. at their Redmond, Washington headquarters or through your authorized representative to receive instructions on the firm-initiated corrective action.
  5. Consult with your healthcare provider or medical facility's technical department regarding any diagnostic reports generated using exported data from these specific software versions.
  6. For additional questions, contact the FDA medical device recall line at 1-888-463-6332.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer Notification and Guidance

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

Affected Products

Product: Kosmos on iOS Ultrasound System (Model P007639)
Model / REF:
P007639
UPC Codes:
09353278000717
Lot Numbers:
Software version: 1.0
Product: Kosmos on iOS Ultrasound System (Model P007944)
Model / REF:
P007944
UPC Codes:
09353278000762
Lot Numbers:
Software versions: 2.1, 2.2

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94709
Status: Active
Manufacturer: Echonous Inc
Sold By: Authorized medical device distributors; Direct sales
Manufactured In: United States
Units Affected: 272
Distributed To: Idaho, Texas, Wisconsin, Kansas, Illinois, Georgia, Michigan, California, Ohio, Florida, Alaska, Utah, Maryland, New York, Nevada, Colorado, North Dakota, Washington, District of Columbia, Louisiana, Kentucky, Minnesota, Hawaii, New Mexico, Tennessee, New Jersey, Vermont, Arizona, Missouri, Alabama, Massachusetts, North Carolina

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.