Recall Z-2317-2024— GE Vingmed Ultrasound As
Class II · Ongoing
Class II FDA medical device recall by GE Vingmed Ultrasound As, initiated 2024-05-02. It names one FDA 510(k) clearance: K142323. Product: GE Vivid Ultrasound products, Model Numbers: a) Vivid S70, H45041SW. Reason: 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..
- Recalling firm
- GE Vingmed Ultrasound As
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-05-02
- Firm location
- Horten, N/A, Norway
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.