Summary
The FDA issued a Class II for GE Healthcare Vivid S70N, ultrasound device by GE Vingmed Ultrasound As. Reason: GE HealthCare has become aware that certain Vivid ultrasound systems cannot boot up in a timely fashion. If this occurs, it can delay availability of .
Details
Source
Device Recall
External ID
Z-2127-2023
Action Date
2023-07-19
Status
Ongoing
Category
device
Product Description
GE Healthcare Vivid S70N, ultrasound device
Lot/Code Info: Software versions: v203, v204, v205, v206
Quantity Affected: N/A
Reason for Recall
GE HealthCare has become aware that certain Vivid ultrasound systems cannot boot up in a timely fashion. If this occurs, it can delay availability of the device in time-critical emergency situations.
Distribution
Worldwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-05-30
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 165 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-2127-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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