Recall Z-0345-2024— Aizu Olympus Co., Ltd.

Name: FDA recall Z-0345-2024
Creator: U.S. Food and Drug Administration
Published: 2023-09-25

Class II · Ongoing

Class II FDA medical device recall by Aizu Olympus Co., Ltd., initiated 2023-09-25. It names one FDA 510(k) clearance: K093507. Product: Ultrasonic gastrovideoscope-Real time ultrasound imaging,ultrasound guided needle aspiration and other endoscopic procedures within the upper gastrointestinal tract and surrounding organs Model Number: TGF-UC180J.. Reason: Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection.

Recalling firm: Aizu Olympus Co., Ltd.
Classification: Class II
Status: Ongoing
Initiated: 2023-09-25
Firm location: Aizuwakamatsu, N/A, Japan

510(k) clearances named in this recall

1 on FDA's record

K093507 — OLYMPUS CHF TYPE Y0003Olympus Medical Systems Corporation·cleared 2010-03-10

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-Real time ultrasound imaging,ultrasound guided needle aspiration and other endoscopic procedures within the upper gastrointestinal tract and surrounding organs Model Number: TGF-UC180J.

Reason for recall

Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection

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