Recall Z-0418-2024— Aizu Olympus Co., Ltd.

Name: FDA recall Z-0418-2024
Creator: U.S. Food and Drug Administration
Published: 2023-10-16

Class II · Ongoing

Class II FDA medical device recall by Aizu Olympus Co., Ltd., initiated 2023-10-16. It names one FDA 510(k) clearance: K131780. Product: PCF-H190DL, EVIS EXERA III COLONOVIDEOSCOPE. Reason: Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in loss of image, decreased suction, or impact the ability to effectively reprocess the device. This in turn may lead to unanticipated delay to treatment, or patient exposure to contaminated material and subsequent infection..

Recalling firm: Aizu Olympus Co., Ltd.
Classification: Class II
Status: Ongoing
Initiated: 2023-10-16
Firm location: Aizuwakamatsu, Japan

510(k) clearances named in this recall

1 on FDA's record

K131780 — EVIS EXERA III VIDEO SYSTEMOlympus Medical Systems Corp.·cleared 2013-08-29

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

PCF-H190DL, EVIS EXERA III COLONOVIDEOSCOPE

Reason for recall

Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in loss of image, decreased suction, or impact the ability to effectively reprocess the device. This in turn may lead to unanticipated delay to treatment, or patient exposure to contaminated material and subsequent infection.

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