Recall Z-0329-2024— Aizu Olympus Co., Ltd.

Name: FDA recall Z-0329-2024
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 6 FDA 510(k) clearances: K111756, K112680, K100584 and 3 more. Product: Colonoscope: for endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve). Model Numbers: CF-2T160I, CF-2T160L, CF-H170I, CF-H170L, CF-H180AI, CF-H180AL, CF-H180DI, CF-H180DL, CF-H190I, CF-H190L, CF-HQ190I, CF-HQ190L, CF-LV1I, CF-LV1L, CF-Q150I, CF-Q150L, CF-Q160S, CF-Q180AI, CF-Q180AL. 510(k) Numbers: K954451, K112680, K100584, K051645, K111756, K001241, K911278.. 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

6 on FDA's record

K111756 — V1 SYSTEMOlympus Medical Systems Corp.·cleared 2012-03-20
K112680 — EVIS EXERA III VIDEO SYSTEMOlympus Medical Systems Corporation·cleared 2012-02-16
K100584 — EVIS EXERAII 180 SYSTEMOlympus Medical Systems Corporation·cleared 2010-07-02
K051645 — EVIS EXERA 160A SYSTEMOlympus Medical Systems Corporation·cleared 2005-10-13
K001241 — EVIS EXERA COLONOVIDEOSCOPE CF-Q160 AL/I AND PCF-160 AL/IThe Olympus Optical Co.·cleared 2000-05-09
K954451 — EVIS 140 SYSTEMOlympus America, Inc.·cleared 1996-03-29

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

Colonoscope: for endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve). Model Numbers: CF-2T160I, CF-2T160L, CF-H170I, CF-H170L, CF-H180AI, CF-H180AL, CF-H180DI, CF-H180DL, CF-H190I, CF-H190L, CF-HQ190I, CF-HQ190L, CF-LV1I, CF-LV1L, CF-Q150I, CF-Q150L, CF-Q160S, CF-Q180AI, CF-Q180AL. 510(k) Numbers: K954451, K112680, K100584, K051645, K111756, K001241, K911278.

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.