Kosmos on iOS impacting iOS, Model Numbers: P007639, P007944, software is part of a general-purpose diagnostic ultrasoun

FDA device recall Z-2325-2024 · posted 2024-07-10 · Open, Classified

Recall details

Recalling firm

Echonous Inc

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.

Action taken

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

Root cause

Software Design Change

Status

Open, Classified

Product code

IYN

Quantity affected

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 Kin

Date initiated

2024-05-09

Date posted

2024-07-10

Location

Redmond, WA

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