Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2325-2024 — Kosmos on iOS impacting iOS, Model Numbers: P007639, P007944, software is part of a general-purpose diagnostic ultrasound system.

U.S. FDA — Device Enforcement · United States · 2024-05-09 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2325-2024
Date of alert
2024-05-09
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Echonous Inc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
09353278000717
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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