GE Vivid Ultrasound products recall
GE Vivid Ultrasound products, Model Numbers: a) Vivid E90, H45581LB; b) Vivid E95, H45581DA
Why was GE Vivid Ultrasound products 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
a) H45581LB, UDI/DU *, Serial Numbers: AU01170, AU01180, AU50159; b) H45581D, UDI/DI *, Serial numbers: AU01095, AU50476, AU50252, AU01002
- Product
- GE Vivid Ultrasound products, Model Numbers: a) Vivid E90, H45581LB; b) Vivid E95, H45581DA
- Recalling firm
- GE Vingmed Ultrasound As
- Quantity
- 7 units
- Distribution
- US: IL, MA, NM, NY, OK,
- Recall date
- July 17, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)