Recall Z-1034-2022— Olympus Corporation of the Americas

Name: FDA recall Z-1034-2022
Creator: U.S. Food and Drug Administration
Published: 2022-03-18

Class II · Ongoing

Class II FDA medical device recall by Olympus Corporation of the Americas, initiated 2022-03-18. It names one FDA 510(k) clearance: K011314. Product: Ultrasonic Gastrovideoscope, GF-UC140P-AL5. Intended for endoscopic real-time ultrasound imaging.. Reason: GF-UC140P-AL5 is no longer a compatible endoscope for reprocessing in the OER-Pro and presents an infection control risk to patients.

Recalling firm: Olympus Corporation of the Americas
Classification: Class II
Status: Ongoing
Initiated: 2022-03-18
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

Ultrasonic Gastrovideoscope, GF-UC140P-AL5. Intended for endoscopic real-time ultrasound imaging.

Reason for recall

GF-UC140P-AL5 is no longer a compatible endoscope for reprocessing in the OER-Pro and presents an infection control risk to patients

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