Medical Device Recall: Kosmos on iOS impacting iOS, Model Numbers: P007639, P007944, software is part of a general-purpose diagnostic ultrasound system.
Echonous Inc · May 9, 2024
Reason for Recall
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.
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
States Affected
AK, AL, AZ, CA, CO, DC, FL, GA, HI, ID, IL, KS, KY, LA, MA, MD, MI, MN, MO, NC, ND, NJ, NM, NV, NY, OH, TN, TX, UT, VT, WA, WI
Quantity Affected
272
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2325-2024
Status: ongoing
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