Echonous Inc Kosmos on iOS impacting iOS, Model Numbers: P007639, P007944, software is part of a general-purpose diagnostic ultrasound system. Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Kosmos on iOS impacting iOS, Model Numbers: P007639, P007944, software is part of a general-purpose diagnostic ultrasound system.
Brand
Echonous Inc
Lot Codes / Batch Numbers
Model/UDI-DI/Software versions: P007639/09353278000717/1.0, P007944/09353278000762/ 2.1, 2.2.
Products Sold
Model/UDI-DI/Software versions: P007639/09353278000717/1.0, P007944/09353278000762/ 2.1, 2.2.
Echonous Inc is recalling Kosmos on iOS impacting iOS, Model Numbers: P007639, P007944, software is part of a general-purpose due to Ultrasound system has a bug in affected iOS software, which after DICOM export, can cause inaccuracy in postprocessed measurements done in 3rd party s. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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 currently installed Kosmos Ultrasound app and from the home screen go to "Settings" > "DICOM". Write down your MWL and PACS profiles. You will need to reference these profiles after you download the new app. Please note: your MWL and PACS profiles will not be retained when you download the new app. If you don't use DICOM or MWL then you can skip this step. 2. Export any images or clips you wish to keep via USB or DICOM. Please note: existing images or clips will not be retained when you download the new app. 3. Delete the Kosmos Ultrasound app that is currently on your iPad(s) 4. Download Kosmos Ultrasound 2.1.4.53 from the Apple App store 5. Connect your iPad(s) to Wi-Fi and open the Kosmos Ultrasound 2.1.4.53 app to download any purchased licenses and when prompted enable drivers 6. From the home screen go to "Settings" > "DICOM" and reconfigure your MWL and PACS profiles with the profile information you wrote down in step 1. If you don't use DICOM or MWL then you can skip this step also. Fill out and return the acknowledgement form. Questions or concerns can be directed to Customer Service at (844) 854-0800 service@echonous.com
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
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
Page updated: Jan 10, 2026