EVIS EXERA II Gastrointestinal Videoscope Recalled for Incorrect Component Fit
Olympus is recalling 8 EVIS EXERA II gastrointestinal videoscopes (Model GIF-HQ190) because an incorrect rubber component may have been installed during repair. The incorrect part does not meet the device's design 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 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: FDA Class II medical device with a confirmed component specification deviation. No injuries have been reported, but an improper component fit in a gastrointestinal endoscope constitutes a risk-of-harm product where injury has not yet been reported, meeting the rubric criterion for High-level severity.
Plain-English summary
Olympus Corporation of the Americas is recalling 8 units of the EVIS EXERA II gastrointestinal videoscope, Model GIF-HQ190. These units were distributed in Alabama, Florida, North Carolina, and New York. During repair at Olympus, an incorrect rubber component (A-rubber) intended for a different gastrointestinal videoscope model may have been installed.
The incorrect component fits tighter on the GIF-HQ190 than intended and does not meet the device's design specifications. The affected units have serial numbers: 2269931, 2611873, 2613235, 2634251, 2634326, 2860721, 2961773, and 2962545.
Patients and healthcare facilities with affected devices should contact Olympus Corporation of the Americas for further instructions.
The recalled product
- Product
- EVIS EXERA II Gastrointestinal Videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). Model: GIF-HQ190
- Manufacturer
- Olympus Corporation of the Americas
- Hazard
- Affected units
- 8
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 (7)
- UDI-DI: 04953170305276 Serial: 2269931
- 2611873
- 2613235
- 2634251
- 2634326
- 2860721
- 2961773 and 2962545
Distribution
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