Ultrasound EA (Ergonomic Advantage) table versions; G3 Multi-Specialty Echocardiography and Multi-Specialty with Electri
Summary
The FDA issued a Class II for Ultrasound EA (Ergonomic Advantage) table versions; G3 Multi-Specialty Echocardi by Oakworks Inc. Reason: Backrest platform stress fracture - the table is not operational in an inclined position.
Details
Source
Device Recall
External ID
Z-0729-2024
Action Date
2024-01-24
Status
Ongoing
Category
device
Product Description
Ultrasound EA (Ergonomic Advantage) table versions; G3 Multi-Specialty Echocardiography and Multi-Specialty with Electric Access Back Supports [left & right}
Lot/Code Info: (UDI): 00817463025422 S/N: USM839457 USM839458 USM839459 USM839460 USM839461 USM818212 USM833897 USW813999 USM839614 USM839615 USM814871 USM833507 USM831797 USM823858 USM822620 USM824500 USM834529 USM788091 USM815794 USM832170
Quantity Affected: 20 units
Reason for Recall
Backrest platform stress fracture - the table is not operational in an inclined position
Distribution
US Nationwide Distribution
Type: Voluntary: Firm initiated
Recall Initiated: 2023-12-05
Company
New Freedom, PA
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 203 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Oakworks Inc has 7 FDA actions in our database, including 7 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 (Oakworks Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Oakworks Inc have FDA actions?
Oakworks Inc has 7 FDA actions in our database, including 7 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0729-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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