EVIS EXERA BF-XT160 Bronchofibervideoscope, Model No. BF-XT160
Reported: September 29, 2021 Initiated: August 17, 2021 #Z-2497-2021
Product Description
EVIS EXERA BF-XT160 Bronchofibervideoscope, Model No. BF-XT160
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.
Details
- Recalling Firm
- Olympus Corporation of the Americas
- Units Affected
- 27 globally (21 US)
- Distribution
- US Nationwide distribution in the states of CA, IL, MA, MD, MI, NY, OH, OR, and PA.
- Location
- Center Valley, PA
Frequently Asked Questions
What product was recalled? ▼
EVIS EXERA BF-XT160 Bronchofibervideoscope, Model No. BF-XT160. Recalled by Olympus Corporation of the Americas. Units affected: 27 globally (21 US).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 29, 2021. Severity: Moderate. Recall number: Z-2497-2021.
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