Z-2317-2024 Class II Ongoing
FDA device recall Z-2317-2024 was initiated by GE Vingmed Ultrasound As on May 2, 2024 and is designated Class II. 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 ultr… The recall status is ongoing. Affected quantity: 1 unit.
Recall Details
- Product Type
- Devices
- Report Date
- July 17, 2024
- Initiation Date
- May 2, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 unit
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.
Distribution Pattern
US: IL, MA, NM, NY, OK,
Code Information
a) H45041SW, UDI/DI *, Serial Numbers: 001423S70