Small intestinal videoscope recalled due to inadequate channel drying process
Aizu Olympus is recalling small intestinal videoscopes (Model SIF-Q180) because the channel air drying process was not properly validated. Water remaining in the channels could cause contamination and infection risk.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a risk-of-harm medical device recall where the potential for infection exists due to contamination from inadequate channel drying validation, but no illnesses or injuries have been reported. The theoretical hazard falls under the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Aizu Olympus Co., Ltd. is recalling the small intestinal videoscope Model SIF-Q180, a medical instrument used for endoscopy and endoscopic surgery of the digestive tract. The recall affects 32 units that have been distributed worldwide, including throughout the United States.
The company determined that the channel air drying process was not properly validated during the repair procedure. A small percentage of scopes returned to customers after repair were found to have water remaining in the channels. Water in the channels creates a risk of contamination that could lead to infection.
The recalled product
- 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…
- Manufacturer
- Aizu Olympus Co., Ltd.
- Affected units
- 32
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Model Number (UDI-DI): SIF-Q180 (04953170339936)
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 22 recalled by Aizu Olympus Co., Ltd. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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