FDA Device Recall Z-0193-2024

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 b BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-XT190

Lot / serial / GTIN: Model BF-XT190 UDI-DI: 4953170402470

Quantity: 719 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-0193-2024
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.

‹ All device recalls