Recalls / —

—#204331

Product

TRACHEAL INTUBATION FIBERSCOPE OLYMPUS LF-GP, Model Number: LF-GP

FDA product code

EOQ — Bronchoscope (Flexible Or Rigid)

Device class

Class 2

Medical specialty

Ear, Nose, Throat

510(k) numbers

K981543

Affected lot / code info

UDI-DI: 04953170340215 & UDI-DI: 04953170061998. Serial numbers: 2515143, 2515181, 2515449, 2515549, 2615760, 2615761, 2615763, 2615825, 2615830, 2615831, 2616057, 2616130, 2616199, 2716417, 2817430, 2917855, 2917867, 2917997, 2918003, 2918010, 2918012, 2918030, 2018337, 2018435, 2018486, 2018543, 2018571, 2018675, 2319768, 2319820, 2510582, 2621001.

Why it was recalled

Fiberscopes do not have adequate data to support that the suction flow rate meets the device specification.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

An Urgent Medical Device notification dated November 1, 2023 issued via UPS Ground. The notice advises customers to examine inventory for affected serial numbers and quarantine affected product. Contact Olympus Customer Solutions Team (1-800-848-9024, option 3) to arrange for for return. Olympus will inspect and repair if necessary. Customers are to forward notice to any facility affected product may have been transferred to. Olympus requests that you acknowledge receipt of this letter with Tara.Safi@Olympus.com.

Recalling firm

Firm

Olympus Corporation of the Americas

Address

3500 Corporate Pkwy, Center Valley, Pennsylvania 18034-8229

Distribution

Distribution pattern

Worldwide - US Nationwide distribution in the states of AK, AL, AZ, CA, GA, IL, IN, MA, MD, MI, NC, NJ, OH, TX, UT, VA, WA, WV & AP (Armed Forces Pacific) and the countries of OUS: EMEA, Japan and Australia.

Timeline

Recall initiated

2023-09-28

Posted by FDA

2023-12-14

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #204331. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.