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
