Olympus OES BRONCHOFIBERSCOPE BF Type, Model Numbers BF-XT40, BF-P60, BF-MP60, BF-1T60
Summary
The FDA issued a Class I for Olympus OES BRONCHOFIBERSCOPE BF Type, Model Numbers BF-XT40, BF-P60, BF-MP60, B by Olympus Corporation of the Americas. Reason: There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope..
Details
Source
Device Recall
External ID
Z-2011-2023
Action Date
2023-07-26
Status
Ongoing
Category
device
Product Description
Olympus OES BRONCHOFIBERSCOPE BF Type, Model Numbers BF-XT40, BF-P60, BF-MP60, BF-1T60
Lot/Code Info: All serial numbers BF-XT40** OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE XT40 UDI: 04953170055980 BF-P60 OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE P60 UDI: 04953170339288 BF-MP60 OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE MP60 UDI: 04953170338394 BF-1T60 OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE 1T60 UDI: 04953170339264
Quantity Affected: 1535 units
Reason for Recall
There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope.
Distribution
US Nationwide Distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-06-08
Company
Center Valley, PA
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 192 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 I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
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-2011-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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