Z-2325-2024Class II

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

Name: Z-2325-2024 Kosmos on iOS impacting iOS, Model Numbers: P007639, P007944, software is part of a general-purpose...
Creator: Echonous Inc
Published: 2024-05-09
License: https://open.fda.gov/license/

Echonous Inc / initiated 2024-05-09 / Open, Classified / root cause: software

FDA source

Echonous Inc began a recall of Kosmos on iOS impacting iOS, Model Numbers: P007639, P007944, software is part of a general-purpose diagnostic ultrasound system on 2024-05-09. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2325-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-05-09
Posted: 2024-07-10
Recalling firm: Echonous Inc
Product: Kosmos on iOS impacting iOS, Model Numbers: P007639, P007944, software is part of a general-purpose diagnostic ultrasound system.
Product code: IYN System, Imaging, Pulsed Doppler, Ultrasonic
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.
Root cause tag: software
FDA 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 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]
Quantity 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
Product codes and lots: Model/UDI-DI/Software versions: P007639/09353278000717/1.0, P007944/09353278000762/ 2.1, 2.2.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2325-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2325-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-17	2024-07-10

Product code IYN

K212100Class IIKosmosEchoNous, Inc. / cleared 2021-08-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)