Respironics California, LLC recalls Philips Respironics V60 Plus Ventilator Part Number 1138747 - Product Usage: intended to be used only with various comb…

Recall date

November 2, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0915-2021

FDA classification

Class II

Brand / firm

Respironics California, LLC

Sold / distributed

Worldwide distribution - US Nationwide including Guam and Puerto Rico; Afghanistan, Albania, Algeria, Andorra, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bhutan, Bolivia, Brazil, Bulgaria, Burkina Faso, Cambodia, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Den…

Why it was recalled

Potential issues with ventilator navigation ring interface and liquid ingress: 1) The navigation ring may become inoperative or operate intermittently; 2) The navigation ring may cause ventilator parameter values to change erratically during setting entries and adjustments.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Philips Respironics V60 Plus Ventilator Part Number 1138747 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.