Recall Z-0333-2024— Aizu Olympus Co., Ltd.
Class II · Ongoing
Class II FDA medical device recall by Aizu Olympus Co., Ltd., initiated 2023-09-25. It names 3 FDA 510(k) clearances: K093395, K051541, K011314. Product: Gastroscope-endoscopic ultrasound (EUS) guided fine needle aspiration (FNA) and for endoscopic surgery within the upper digestive tract. Model Numbers: GF-UC140P-AL5, GF-UCT180, GF-UE160-AL5.. 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
3 on FDA's record- K093395 — OLYMPUS GF TYPE UC180, OLYMPUS GF TYPE UCT180 EVIS EXERA II ULATRASOUND GASTROVIDEOSCOPE
- K051541 — GF-UE160-AL5 ULTRASOUND ENDOSCOPE
- K011314 — OLYMPUS GF UC140P-AL5 ULTRASONIC ENDOSCOPE WITH ALOKA SSD-5500 ULTRASOUND SYSTEM
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
Gastroscope-endoscopic ultrasound (EUS) guided fine needle aspiration (FNA) and for endoscopic surgery within the upper digestive tract. Model Numbers: GF-UC140P-AL5, GF-UCT180, GF-UE160-AL5.
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.