Summary
The FDA issued a Class II for Colonovideoscope Model CF-H180AL by Olympus Corporation of the Americas. Reason: A (Camera unit) CCD intended for a different model of colonoscope may have been installed in the CF-H180AL, viewing angle would be narrower than a nor.
Details
Source
Device Recall
External ID
Z-1274-2022
Action Date
2022-06-29
Status
Terminated
Category
device
Product Description
Colonovideoscope Model CF-H180AL
Lot/Code Info: UDI-DI: 04953170339615 Serial number: 2501131
Quantity Affected: 1 unit
Reason for Recall
A (Camera unit) CCD intended for a different model of colonoscope may have been installed in the CF-H180AL, viewing angle would be narrower than a normal CF-H180AL and the use of EndoTherapy devices may stick out (approximately 1.4 mm) further than normal protrusion,could lead to patient injury; specifically, mucosal damage that could result in hemorrhage or bleeding
Distribution
US Nationwide distribution in the state of KY.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-04-22
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 107 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-1274-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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