EVIS EXERA BF-XT160 Bronchofibervideoscope, Model No. BF-XT160
Summary
The FDA issued a Class II for EVIS EXERA BF-XT160 Bronchofibervideoscope, Model No. BF-XT160 by Olympus Corporation of the Americas. Reason: A gluing step was not performed during the manufacturing of the affected device's insertion tube. There is a potential for the insertion tube to devel.
Details
Source
Device Recall
External ID
Z-2497-2021
Action Date
2021-09-29
Status
Terminated
Category
device
Product Description
EVIS EXERA BF-XT160 Bronchofibervideoscope, Model No. BF-XT160
Lot/Code Info: 1200148 2500873 2100707 2710983 1500300 1400209 2600505 1300163 1400273 1400248 2700521 2500431 1500310 1200129 2300805 2811029 1500292 2700520 2100743 1500313 2911060
Quantity Affected: 27 globally (21 US)
Reason for Recall
A gluing step was not performed during the manufacturing of the affected device's insertion tube. There is a potential for the insertion tube to develop a leak, which poses an infection control risk.
Distribution
US Nationwide distribution in the states of CA, IL, MA, MD, MI, NY, OH, OR, and PA.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-08-17
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 173 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-2497-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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