Recall Z-0327-2024— Aizu Olympus Co., Ltd.

Name: FDA recall Z-0327-2024
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: K201758, K172726, K121959 and 3 more. Product: Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. Model Numbers: BF-1T150, BF-1T60, BF-1TH190, BF-1TQ170, BF-3C160, BF-3C40, BF-H190, BF-MP190F, BF-MP60, BF-P150, BF-P190, BF-P60, BF-Q170, BF-Q190, BF-XP190, BF-XP60, BF-XT160, BF-XT190. 510(k)s: K023984, K121959, K963033, K172726, K201758, K033225, K183419.. 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

K201758 — EVIS EXERA III Bronchovideoscope Olympus BF-XP190, EVIS EXERA III Bronchovideoscope Olympus BF-P190Olympus Medical Systems Corp.·cleared 2021-01-21
K172726 — EVIS EXERA III BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-MP190F, Single Use Biopsy Forceps FB-433DOlympus Medical Systems Corp.·cleared 2018-04-30
K121959 — EVIS EXERA III VIDEO SYSTEMOlympus Medical Systems Corp.·cleared 2013-01-10
K033225 — EVIS EXERA BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE XP160F, ITS ACCESSORIES AND ANCILLARY EQUIPMENTOlympus Optical Co., Ltd.·cleared 2003-10-16
K023984 — MODIFICATION TO OLYMPUS BRONCHOSCOPES BF-40 SERIES, BF-240 SERIES, AND BF-160 SERIESThe Olympus Optical Co.·cleared 2003-01-31
K963033 — BF 240/P240/IT240 BRONCHOVIDEOSCOPE & ACCESSORIESOlympus America, Inc.·cleared 1996-09-09

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

Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. Model Numbers: BF-1T150, BF-1T60, BF-1TH190, BF-1TQ170, BF-3C160, BF-3C40, BF-H190, BF-MP190F, BF-MP60, BF-P150, BF-P190, BF-P60, BF-Q170, BF-Q190, BF-XP190, BF-XP60, BF-XT160, BF-XT190. 510(k)s: K023984, K121959, K963033, K172726, K201758, K033225, K183419.

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.