Recall Z-0498-2021— Olympus Corporation of the Americas

Name: FDA recall Z-0498-2021
Creator: U.S. Food and Drug Administration
Published: 2020-10-16

Class II · Terminated

Class II FDA medical device recall by Olympus Corporation of the Americas, initiated 2020-10-16, terminated 2022-06-07. It names one FDA 510(k) clearance: K011314. Product: Olympus Ultrasound Endoscope, Model number: GF-UCT140P-AL5 - Product Usage: used with other supporting equipment for endoscopic real-time ultrasound imaging and endoscopic surgery within the gastrointestinal tract.. Reason: A new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for this device in order to reduce the risk of causing patient infections..

Recalling firm: Olympus Corporation of the Americas
Classification: Class II
Status: Terminated
Initiated: 2020-10-16
Terminated: 2022-06-07
Firm location: Center Valley, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K011314 — OLYMPUS GF UC140P-AL5 ULTRASONIC ENDOSCOPE WITH ALOKA SSD-5500 ULTRASOUND SYSTEMAloka Co., Ltd.·cleared 2001-05-15

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Olympus Ultrasound Endoscope, Model number: GF-UCT140P-AL5 - Product Usage: used with other supporting equipment for endoscopic real-time ultrasound imaging and endoscopic surgery within the gastrointestinal tract.

Reason for recall

A new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for this device in order to reduce the risk of causing patient infections.

Data sourced from openFDA. This site is unofficial and independent of the FDA.