GE Vivid Ultrasound products, Model Numbers: a) Vivid S70, H45041SW
Summary
The FDA issued a Class II for GE Vivid Ultrasound products, Model Numbers: a) Vivid S70, H45041SW by GE Vingmed Ultrasound As. 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 .
Details
Source
Device Recall
External ID
Z-2317-2024
Action Date
2024-07-17
Status
Ongoing
Category
device
Product Description
GE Vivid Ultrasound products, Model Numbers: a) Vivid S70, H45041SW
Lot/Code Info: a) H45041SW, UDI/DI *, Serial Numbers: 001423S70
Quantity Affected: 1 unit
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
US: IL, MA, NM, NY, OK,
Type: Voluntary: Firm initiated
Recall Initiated: 2024-05-02
Company
Horten, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 188 device recalls issued in the same week, part of 403 device-related FDA actions this month.
GE Vingmed Ultrasound As has 6 FDA actions in our database, including 6 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (GE Vingmed Ultrasound As) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does GE Vingmed Ultrasound As have FDA actions?
GE Vingmed Ultrasound As has 6 FDA actions in our database, including 6 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2317-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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