Olympus High Flow Insufflation Unit Model UHI-2 Recalled Due to Software Issue
Olympus Corporation of the Americas is recalling 744 Olympus High Flow Insufflation Units (Model UHI-2) because a software algorithm issue may cause overpressure events.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The recall is classified as FDA Class I, which indicates a situation where there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
Plain-English summary
Olympus Corporation of the Americas is recalling the Olympus High Flow Insufflation Unit, Model UHI-2. This device is used for abdominal cavity insufflation, as well as automatic suction and smoke evacuation during laparoscopic procedures.
A software algorithm issue in the device may lead to overpressure events during use.
This recall affects 744 units distributed nationwide. Users should follow manufacturer instructions regarding the affected devices.
The recalled product
- Product
- Olympus High Flow Insufflation Unit. Model/ Number: UHI-2. Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuation to facilitate laparoscopic observation and treatment within the abdominal cavity.
- Manufacturer
- Olympus Corporation of the Americas
- Affected units
- 744
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: UHI-2
- UDI-DI: N/A
- All Serial Numbers
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 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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