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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = CBK
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