Olympus High Flow Insufflation Unit UHI-4 Recalled Due to Display and Air Delivery Failure
Olympus Corporation of the Americas is recalling the Olympus High Flow Insufflation Unit (Model UHI-4) because the front panel display may turn off unexpectedly, causing air delivery to cease.
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: The product is a medical device where a failure in air delivery (insufflation) represents a high-risk hazard where injury has not yet been reported.
Plain-English summary
Olympus Corporation of the Americas has issued a recall for the Olympus High Flow Insufflation Unit, Model UHI-4. This recall affects 3,087 units distributed worldwide, including throughout the United States and several other countries.
The issue involves a potential for the front panel display to turn off unexpectedly. If this occurs, the air delivery (insufflation) will also cease.
Users should be aware of this potential failure in the UHI-4 model. Affected units include all serial numbers with UDI 04953170324147 and 04953170467219.
The recalled product
- Product
- Olympus High Flow Insufflation Unit - UHI-4. Model Number: UHI-4
- Manufacturer
- Olympus Corporation of the Americas
- Affected units
- 3,087
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 (2)
- Model Number: UHI-4. UDI: 04953170324147
- 04953170467219. All Serial Numbers.
Distribution
Distributed nationwide across the United States.
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