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Kosmos on iOS impacting iOS, Model Numbers: P007639… recallZ-2325-2024 · Echonous Inc · initiated May 9, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Echonous Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Software Design Change

What the company is doing

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 [email protected]

Recall details

Recall number
Z-2325-2024
Status
Open, Classified
Initiated by the company
May 9, 2024
Posted by the FDA
Jul 10, 2024
Recalling firm
Echonous Inc
Quantity
272
Product code
IYN
FDA submissions
K212100
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

Product description

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

Code information (models, lots, serial numbers)

Model/UDI-DI/Software versions: P007639/09353278000717/1.0, P007944/09353278000762/ 2.1, 2.2.

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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