Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Kosmos on iOS impacting iOS Recalled by Echonous Inc Due to Ultrasound system has a bug in affected iOS...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Echonous Inc directly.
Affected Products
Kosmos on iOS impacting iOS, Model Numbers: P007639, P007944, software is part of a general-purpose diagnostic ultrasound system.
Quantity: 272
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 32 states: AL, AK, AZ, CA, CO, FL, GA, HI, ID, IL, KS, KY, LA, MD, MA, MI, MN, MO, NV, NJ, NM, NY, NC, ND, OH, TN, TX, UT, VT, WA, WI, DC
About Echonous Inc
Echonous Inc has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report