Colonovideoscope Model CF-H180AL recalled due to narrowed viewing angle
Olympus Corporation recalls a single colonovideoscope model CF-H180AL because an incorrect camera unit was installed, causing narrower viewing angle and potential device protrusion that could injure tissue. No injuries have been reported.
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 device recall with no reported illnesses or injuries. The hazard is mechanical—an incorrect camera unit causing narrowed viewing angle and potential device protrusion—creating a risk of mucosal damage and internal bleeding, which qualifies as a high-risk condition where injury has not yet been reported.
Plain-English summary
Olympus Corporation of the Americas is recalling a single Colonovideoscope Model CF-H180AL (Serial number 2501131) distributed in the United States. The device contains an incorrect camera unit.
A camera unit intended for a different colonoscope model was installed in this CF-H180AL. This causes the viewing angle to be narrower than normal, and therapeutic instruments used with the device may protrude approximately 1.4 millimeters further than they should.
These defects could cause patient injury through mucosal damage or internal bleeding. No injuries have been reported to date.
Healthcare facilities that have received this specific unit should contact Olympus Corporation to arrange a return or replacement.
The recalled product
- Product
- Colonovideoscope Model CF-H180AL
- Manufacturer
- Olympus Corporation of the Americas
- Affected units
- 1
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: 04953170339615 Serial number: 2501131
Distribution
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