Class II — Echonous Inc
| Recalling firm | ECHONOUS, INC. |
|---|---|
| Registered facility | ECHONOUS, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| 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. |
| Product | Kosmos on iOS impacting iOS, Model Numbers: P007639, P007944, software is part of a general-purpose diagnostic ultrasound system. |
| Quantity | 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 |
| Initiated | 2024-05-09 |
| Classified | 2024-07-10 |
| Recall number | Z-2325-2024 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Echonous Inc (Z-2325-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/94709/
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