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U.S. Department of Health and Human Services

Class 2 Device Recall Esprit Ventilator

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  Class 2 Device Recall Esprit Ventilator see related information
Date Initiated by Firm October 29, 2007
Date Posted August 26, 2013
Recall Status1 Terminated 3 on August 26, 2013
Recall Number Z-2084-2013
Recall Event ID 48997
510(K)Number K981072  K001208  K023350  K034040  K041412  
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 CA 92011-1517
For Additional Information Contact
760-918-7300
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.
FDA Determined
Cause 2		 Device Design
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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 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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