Recall archive / FDA device enforcement
GE Vivid Ultrasound products, Model Numbers: a) Vivid S70, H45041SW — FDA record Z-2317-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date May 2, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Classification
- Class II
- Recalling firm
- GE Vingmed Ultrasound As
- Quantity
- 1 unit
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2317-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | a) H45041SW, UDI/DI *, Serial Numbers: 001423S70 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US: IL, MA, NM, NY, OK,
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Jul 17, 2024
- Recall initiation date
- May 2, 2024
- Center classification date
- Jul 5, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.