Olympus Corporation of the Americas: Olympus High Flow Insufflation Unit - UHI-4. Model Number: UHI-4

Hazard

Potential for unexpected instances where the front panel display turns off unexpectedly, and air delivery (insufflation) ceases.

Details from the source

Reason for recall: Potential for unexpected instances where the front panel display turns off unexpectedly, and air delivery (insufflation) ceases. Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Ecuador, El Salvador, Germany, Honduras, Hong Kong, India, Ireland, Japan, Korea, Malaysia, Mexico, Myanmar, New Zealand, Paraguay, Peru, Russia, Singapore, Sri Lanka, Taiwan, Thailand, United Kingdom, Uruguay, Vietnam. Quantity: 3,087 units Lot/code info: Model Number: UHI-4. UDI: 04953170324147, 04953170467219. All Serial Numbers.

UPC codes

04953170324147, 04953170467219

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.