FDA Device Recall Z-0194-2024

Olympus Corporation of the Americas · Center Valley, PA

Class I — life-threatening Ongoing

Highest impact — Class I device recall — FDA determination that use of, or exposure to, the device will cause serious adverse health consequences or death. Distribution is nationwide and the recall remains in progress.

Device

EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-P190

Lot / serial / GTIN: Model BF-P190 UDI-DI: 4953170342110

Quantity: 3948 devices

Reason for recall

There is a risk of endobronchial combustion if high-frequency cauterization is performed while supplying oxygen [and/or] the electrode section of the electrosurgical accessory is too close to the distal end of the endoscope.

Recall record

Recall number: Z-0194-2024
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: US Nationwide distribution
Recall initiated: 2023-10-12
Classified by FDA Center: 2023-11-09
FDA published: 2023-11-15
Recalling firm: Olympus Corporation of the Americas
Firm location: Center Valley, PA

Operational response

A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.

For the official FDA enforcement record, see FDA's Recall Search.

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