Recall Z-2325-2024 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Echonous Inc
Kosmos on iOS impacting iOS, Model Numbers: P007639, P007944, software is part of a general-purpose diagnostic ultrasound system.
| Date | Jul 10, 2024 (initiated May 9, 2024) |
| Status | Open, Classified |
| 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. |
| Root cause | Software Design Change |
| Action | On 5/9/24, notices were sent to customers informing them to refrain from performing measurements on Kosmos iOS images with third-party PACS or post-processing software, after DICOM export. Also, they were informed, that a software patch would be ready to upload soon. On 5/22/24, notices were sent to customers informing them that software patch 2.1.4.53 was available and that users should download this software performing measurements on Kosmos iOS images with third-party PACS or post-processing software. Follow the steps below and download this new version as soon as possible: 1. Open your c |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K212100 | Kosmos EchoNous, Inc., Aug 6, 2021 |