Philips North America Llc: IntelliVue Patient Monitor MX500. Product Number: 866064.

Hazard

Potential issue where the IntelliVue monitors did not alarm.

Details from the source

Reason for recall: Potential issue where the IntelliVue monitors did not alarm. Distribution: Worldwide distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Angola, Argentina, Armenia, Aruba, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belgium, Bolivia, Bosnia, Botswana, Brazil, Brunei, Bulgaria, Burundi, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Cote D'Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Quantity: 1,913,441 units Lot/code info: Product Number: 866064; UDI-DI: 00884838038776; All Serial No.

UPC codes

00884838038776

Source

Official record: FDA (Device enforcement) ↗

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