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U.S. Department of Health and Human Services

Class 2 Device Recall Power Board Kit

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  Class 2 Device Recall Power Board Kit see related information
Date Initiated by Firm July 08, 2008
Date Posted September 18, 2008
Recall Status1 Terminated 3 on April 23, 2009
Recall Number Z-2345-2008
Recall Event ID 48980
510(K)Number K832467  
Product Classification Circuit board - Product Code CBK
Product Power Board Kit for use with the PLV-100 Portable Lifecare repairs
Code Information Model/Catalog number PLV-100. Circuit board part numbers 1034786 version 5 or 1036038 version 3
Recalling Firm/
Manufacturer		 Respironics, Inc.
1001 Murry Ridge Ln
Murrysville PA 15668-8550
For Additional Information Contact Customer Service
877-387-3311
Manufacturer Reason
for Recall		 Certain PLV-100 ventilators may not trigger a signal to activate third-party remote alarms or nurse call systems upon device failure.
FDA Determined
Cause 2		 Finished device change control
Action The recalling firm issued an URGENT MEDICAL DEVICE RECALL letter dated 7/8/08. The letter informed the customer of the problem and the need to contact the firm for a replacement. Contact Respironics Customer Service at 1-877-387-331 for assistance.
Quantity in Commerce 197
Distribution Worldwide Distribution ---USA: NC, IL, NJ, MO, TX , OH, IA, and OK and countries of Japan, Denmark, Korea, Australia, Finland, Canada, Argentina, New Zealand, Hong Kong, and India.
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 = LIFECARE SERVICES, INC.
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