FDA Device recall Z-2325-2024
Kosmos on iOS impacting iOS, Model Numbers: P007639, P007944, software is part of a general-purpose diagnostic ultrasound system
- FDA Device
- Class II
- ongoing
- Published 2024-07-17
On 2024-07-17 the FDA classified a Class II recall of Kosmos on iOS impacting iOS, Model Numbers: P007639, P007944, software is part of a general-purpose diagnostic ultrasound system by Echonous, citing 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 othe….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2325-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-05-09 |
| Published | 2024-07-17 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Echonous |
| Distribution | AK, AL, AZ, CA, CO, DC, FL, GA, HI, ID, IL, KS, KY, LA, MA, MD, MI, MN, MO, NC, ND, NJ, NM, NV, NY, OH, TN, TX, UT, VT, WA, WI |
Product
Kosmos on iOS impacting iOS, Model Numbers: P007639, P007944, software is part of a general-purpose diagnostic ultrasound system.
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.
Identifiers
| code_info | Model/UDI-DI/Software versions: P007639/09353278000717/1.0, P007944/09353278000762/ 2.1, 2.2. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2325-2024%22
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