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U.S. Department of Health and Human Services

Class 2 Device Recall Esprit Ventilator

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 Class 2 Recall
Esprit Ventilator
see related information
Date Posted August 26, 2013
Recall Status1 Terminated on August 26, 2013
Recall Number Z-2084-2013
Recall Event ID 48997
Premarket Notification
510(K) Numbers
K001208  K023350  K034040  K041412  K981072 
Product Classification Ventilator, Continuous, Facility Use - Product Code CBK
Product Continuous Ventilator/Continuous Ventilator with Respiratory Mechanics, Model No. V1000
Code Information Model Number: V1000
Recalling Firm/
Manufacturer
Respironics California Inc
2271 Cosmos Ct
Carlsbad, California 92011-1517
Manufacturer 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.
Action A Medical Device Field Correction letter dated 10/26/2007 was sent to all customers who received the Esprit Ventilator. The recall letter informed the customers of the problems identified and the actions to be taken. Customers with questions are instructed to contact Respironics' Customer Service Dept. at (800) 345-6443, select Option#5, then select Option #4.
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
510(K) Database 510(K)s with Product Code = CBK and Original Applicant = RESPIRONICS CALIFORNIA, INC.
510(K)s with Product Code = CBK and Original Applicant = RESPIRONICS, INC.
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