Olympus Gastrointestinal Videoscope Drying Instructions Clarified
Olympus is recalling 1,749 GIF-1TH190 gastrointestinal videoscopes to clarify drying procedures in the instructions for use after human errors were identified during evaluation.
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: FDA Class II recall with no reported illnesses, injuries, or deaths. The recall is a precautionary clarification of drying procedures in the instructions for use, following human errors identified during a Human Factors evaluation.
Plain-English summary
Olympus Corporation of the Americas is recalling 1,749 EVIS EXERA III Gastrointestinal Videoscope model GIF-1TH190 units. The recall addresses the need to clarify and improve the drying procedures described in the instructions for use.
During a Human Factors evaluation of the GIF-1TH190, human errors and concerns were identified when following the current drying procedures. Olympus is revising the instructions to improve the clarity and ease of understanding for each drying step.
The affected videoscopes were distributed domestically throughout the United States. The recall applies to units with serial numbers less than 2446103.
The recalled product
- Product
- Brand Name: EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190 Product Name: Olympus GIF-1TH190 Model/Catalog Number: GIF-1TH190 Software Version: N/A Product Description: This instrument is intended to be used with an Olympus video system center, light source…
- Manufacturer
- Olympus Corporation of the Americas
- Affected units
- 1,749
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 (3)
- Model: GIF-1TH190
- UDI-DI: 04953170343360
- Serial #: Less than 2446103.
Distribution
Distributed nationwide across the United States.
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