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

Recall Z-2317-2024 — GE Vivid Ultrasound products, Model Numbers: a) Vivid S70, H45041SW

U.S. FDA — Device Enforcement · Norway · 2024-05-02 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2317-2024
Date of alert
2024-05-02
Country / jurisdiction
Norway
Risk level
Class II
Risk type
recall
Brand
GE Vingmed Ultrasound As
Product category
device
Product type
Devices
Reported risk: GE HealthCare has become aware of an issue with certain Vivid ultrasound systems where, due to a slow DICOM Worklist response time, incorrect patient name and demographics can be displayed on the ultrasound scanner screen rather than the intended patient selected by the user.
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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