Jul

2024

FDA Recall: Software Bug Can Cause Inaccurate Measurements

Company: Echonous Inc.
Date of Enforcement Report: 7/10/2024
Class II

PRODUCT

Kosmos on iOS impacting iOS, Model Numbers: P007639, P007944, software is part of a general-purpose diagnostic ultrasound system.

Recall Number:

Z-2325-2024

REASON:

Ultrasound system has a bug in affected iOS software, which after DICOM export, can cause inaccuracy in postprocessed measurements done in 3rd party software, such as PACS or other post-processing software, which may lead to inaccurate diagnoses or treatment.

RECALLING FIRM/MANUFACTURER:

Echonous Inc.

VOLUME OF PRODUCT IN COMMERCE:

272

DISTRIBUTION:

US: ID, TX, WI, KS, IL, GA, MI, CA, OH, FL, AK, UT, MD, NY, NV, CO, ND, WA, DC, LA, KY, MN, HI, NM, TN, NJ, ID, MI, VT, AZ, MO, AL, MA, NC OUS: Denmark, Switzerland, Austria, Italy, France, United Kingdom, Germany, Spain, Romania, Finland, Romania, Australia, India, Hong Kong, Thailand

About the author

Allison Pate

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

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FDA Recall: Software Bug Can Cause Inaccurate Measurements

Allison Pate

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