Colonoscope Model CF-HQ190I recalled for missing protective adhesive
Olympus is recalling certain repaired Model CF-HQ190I colonoscopes assembled without protective adhesive, which may cause equipment failure under vibration, temperature changes, or shock.
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 an FDA Class II recall of a medical device without reported injuries or illnesses. The hazard is theoretical equipment failure under certain conditions. Per rubric criteria for risk-of-harm medical products where injury has not been reported, this rates as High.
Plain-English summary
Olympus Corporation of the Americas is recalling certain repaired Model CF-HQ190I colonoscopes that were assembled without a protective adhesive component designed to protect the device during normal use conditions.
The missing adhesive is intended to protect the colonoscope from physical stresses including high vibration, temperature fluctuations, and severe shock loads. Without this component, the device may malfunction during procedures.
These colonoscopes were distributed nationwide in the United States. Healthcare facilities and medical professionals using affected devices should immediately discontinue use and contact Olympus Corporation of the Americas for replacement or repair instructions.
No patient injuries or illnesses have been reported to date.
The recalled product
- Product
- Colonoscope, Model Number CF-HQ190I.
- 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 (3)
- Model Number: CF-HQ190I
- UDI DI: 4953170305139
- Serial Number: 2263354
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 10 recalled by Olympus Corporation of the Americas 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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