FDA recall Z-0343-2024

Aizu Olympus Co., Ltd. · Class II · device

Product

Small intestinal videoscope-For endoscopy and endoscopic surgery within the upper digestive tract (including the esophagus, stomach, duodenum, and small intestine) by oral insertion or the lower digestive tract (including the anus, rectum, sigmoid colon, colon, ileocecal valve, and small intestine) by anal insertion. - Model Number: SIF-Q180.

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

Distribution

Worldwide - US Nationwide distribution.

Key facts

Status
Ongoing
Initiation date
2023-09-25
Report date
2023-11-29
Voluntary/Mandated
Voluntary: Firm initiated
Location
Aizuwakamatsu, N/A, Japan

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0343-2024