Olympus Gastrointestinal Videoscope Recalled Due to Incorrect Sensor Color Correction Programming
Olympus Corporation is recalling the Gastrointestinal Videoscope Model GIF-1100 due to incorrect color correction data programmed into CCD imaging sensors. The affected units do not meet device specifications.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall without reported adverse events or injuries. The defect was identified during routine device performance testing and involves incorrect color correction programming that prevents the device from meeting specifications, representing a quality and functional defect rather than an immediate safety threat.
Plain-English summary
Olympus Corporation of the Americas is recalling the Olympus Gastrointestinal Videoscope, Model GIF-1100. The recall affects 1,407 units distributed nationwide.
During device performance testing, it was discovered that the CCD imaging sensors in affected units were programmed with incorrect color correction data, meaning these devices do not meet specifications.
Affected units can be identified by the serial numbers listed in the FDA recall database. Additional information about the recall can be obtained through the FDA or from Olympus Corporation of the Americas.
The recalled product
- Product
- Olympus Gastrointestinal Videoscope, Model/Catalog Number: GIF-1100
- Manufacturer
- Olympus Corporation of the Americas
- Affected units
- 1,407
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)
- UDI-DI: 04953170420191
Distribution
Distributed nationwide across the United States.
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