OES 4000 Hysteroscope, Model/Catalog Number: A4674A
Summary
The FDA issued a Class II for OES 4000 Hysteroscope, Model/Catalog Number: A4674A by Olympus Corporation of the Americas. Reason: The required leakage test was not performed following of a re-work for a non-conformity. This could potentially result in liquid ingress into the eyep.
Details
Source
Device Recall
External ID
Z-2029-2024
Action Date
2024-06-12
Status
Ongoing
Category
device
Product Description
OES 4000 Hysteroscope, Model/Catalog Number: A4674A
Lot/Code Info: Model/Catalog Number: A4674A, UDI-DI: 04042761006361, Serial Number: 805904;
Quantity Affected: 1 unit
Reason for Recall
The required leakage test was not performed following of a re-work for a non-conformity. This could potentially result in liquid ingress into the eyepiece and cause a foggy image.
Distribution
US Nationwide distribution in the state of NY.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-04-18
Company
Center Valley, 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 212 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Olympus Corporation of the Americas has 334 FDA actions in our database, including 334 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 (Olympus Corporation of the Americas) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Olympus Corporation of the Americas have FDA actions?
Olympus Corporation of the Americas has 334 FDA actions in our database, including 334 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2029-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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