Continuous Ventilator/Continuous Ventilator with Respiratory Mechanics, Model No. V1000
FDA Recall #Z-2084-2013 — Class II — October 29, 2007
Product Description
Continuous Ventilator/Continuous Ventilator with Respiratory Mechanics, Model No. V1000
Reason for Recall
The power to the Esprit Display's Backlight is interrupted, causing the GUI to flicker or go dark and making the display unreadable.
Recalling Firm
Respironics California Inc — Carlsbad, CA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
3,255 units (2302 units in US)
Distribution
USA Nationwide and Worldwide to Algeria, Argentina, Australia, Bangladesh, Brazil, Cambodia, Canada, Chile, Colombia, Ecuador, Egypt, France, Germany, Guatemala, Hong Kong, India, Italy, Japan, Libya, Malaysia, Mexico, Pakistan, Peru, Philippines, Puerto Rico, Russia, South Africa, South Korea, Spain, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, and Vietnam.
Code Information
Model Number: V1000
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated