PlainRecalls
FDA Devices Moderate Class II Ongoing

GE Vivid Ultrasound products, Model Numbers: a) Vivid S70, H45041SW

Reported: July 17, 2024 Initiated: May 2, 2024 #Z-2317-2024

Product Description

GE Vivid Ultrasound products, Model Numbers: a) Vivid S70, H45041SW

Reason for Recall

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.

Details

Recalling Firm
GE Vingmed Ultrasound As
Units Affected
1 unit
Distribution
US: IL, MA, NM, NY, OK,
Location
Horten, N/A

Frequently Asked Questions

What product was recalled?
GE Vivid Ultrasound products, Model Numbers: a) Vivid S70, H45041SW. Recalled by GE Vingmed Ultrasound As. Units affected: 1 unit.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on July 17, 2024. Severity: Moderate. Recall number: Z-2317-2024.