Venue Go Standard Carts Ref: (H45181VC and H45103VCW), used with Venue Go R2, R3, R4 systems R2, R3, and R4 systems; pul
Summary
The FDA issued a Class II for Venue Go Standard Carts Ref: (H45181VC and H45103VCW), used with Venue Go R2, R3 by GE MEDICAL SYSTEMS, ISRAEL LTD.. Reason: Some Venue Go Standard Carts can develop an internal failure of the vertical/horizontal tilt adjustment mechanism which can result in the Venue Go sys.
Details
Source
Device Recall
External ID
Z-2652-2023
Action Date
2023-10-11
Status
Ongoing
Category
device
Product Description
Venue Go Standard Carts Ref: (H45181VC and H45103VCW), used with Venue Go R2, R3, R4 systems R2, R3, and R4 systems; pulsed doppler imaging system
Lot/Code Info: Venue Go Standard Carts, Ref: (H45181VC and H45103VCW) used with Venue Go R2, R3, R4 systems R2, R3, and R4 systems (GTIN 0084068213884, 00840682190503, and 00195278516510) that were manufactured 2022-08 and before
Quantity Affected: 5986 devices
Reason for Recall
Some Venue Go Standard Carts can develop an internal failure of the vertical/horizontal tilt adjustment mechanism which can result in the Venue Go system detaching from the cart and falling.
Distribution
Worldwide distribution - US Nationwide distribution including government and military distribution as well as PR.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-09-06
Company
HAIFA, 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 142 device recalls issued in the same week, part of 403 device-related FDA actions this month.
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 MEDICAL SYSTEMS, ISRAEL LTD.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does GE MEDICAL SYSTEMS, ISRAEL LTD. have FDA actions?
This is the only FDA action we have on record for GE MEDICAL SYSTEMS, ISRAEL LTD. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2652-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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