Summary
The FDA issued a Class II for CF-HQ190L EVIS EXERA III COLONOVIDEOSCOPE by Aizu Olympus Co., Ltd.. Reason: Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope c.
Details
Source
Device Recall
External ID
Z-0415-2024
Action Date
2023-12-06
Status
Ongoing
Category
device
Product Description
CF-HQ190L EVIS EXERA III COLONOVIDEOSCOPE
Lot/Code Info: UDI-DI 04953170305115 Serial Numbers 2635812, 2416423
Quantity Affected: 24 incorrectly repaired units
Reason for Recall
Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in loss of image, decreased suction, or impact the ability to effectively reprocess the device. This in turn may lead to unanticipated delay to treatment, or patient exposure to contaminated material and subsequent infection.
Distribution
Domestic distribution to FL, KY, MA, NJ, NY, and PA
Type: Voluntary: Firm initiated
Recall Initiated: 2023-10-16
Company
Aizuwakamatsu
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 190 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Aizu Olympus Co., Ltd. has 31 FDA actions in our database, including 31 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 (Aizu Olympus Co., Ltd.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Aizu Olympus Co., Ltd. have FDA actions?
Aizu Olympus Co., Ltd. has 31 FDA actions in our database, including 31 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0415-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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