PlainRecalls
FDA Devices Moderate Class II Ongoing

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.

Reported: November 29, 2023 Initiated: September 25, 2023 #Z-0343-2024

Product Description

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

Details

Recalling Firm
Aizu Olympus Co., Ltd.
Units Affected
32 units
Distribution
Worldwide - US Nationwide distribution.
Location
Aizuwakamatsu, N/A

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Aizu Olympus Co., Ltd.. Units affected: 32 units.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 29, 2023. Severity: Moderate. Recall number: Z-0343-2024.

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