Kosmos on iOS impacting iOS — Class II medical device recall Z-2325-2024
Ongoing recall by Echonous Inc, reported 2024-07-17, distributed in AK, AL, AZ, CA, CO, DC, FL, GA…. Ultrasound system has a bug in affected iOS software, which after DICOM export, can cause inaccuracy in postpr
| Recall number | Z-2325-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Echonous Inc, Redmond, WA, United States |
| Recall initiated | 2024-05-09 |
| Classified | 2024-07-10 |
| Reported by FDA | 2024-07-17 |
| Distributed | 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 |
| Countries outside the US | AT, AU, CH, DE, DK, ES, FI, FR, GB, HK, IN, IT, RO, TH |
| Quantity | 272 |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 09353278000717, 09353278000762 |
| Model numbers | P007639, P007944 |
Product
Kosmos on iOS impacting iOS, Model Numbers: P007639, P007944, software is part of a general-purpose diagnostic ultrasound system.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2325-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.