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U.S. Department of Health and Human Services

Class 2 Device Recall Nellcor Puritan Bennett

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  Class 2 Device Recall Nellcor Puritan Bennett see related information
Date Initiated by Firm October 18, 2004
Date Posted March 30, 2005
Recall Status1 Terminated 3 on May 15, 2006
Recall Number Z-0663-05
Recall Event ID 31271
510(K)Number K973147  
Product Classification Oximeter - Product Code DQA
Product Nellcor Puritan Bennett brand Pulse Oximeter, Model NPB295,

Made in Ireland; Distributed by Nellcor Puritan Bennett, Inc. Pleasanton, CA 94588 U.S.A.
Code Information All units with serial numbers beginning with G01844386.
Recalling Firm/
Manufacturer		 Nellcor Puritan Bennett
4280 Hacienda Dr
Pleasanton CA 94588-2719
For Additional Information Contact Nellcor Technical Services
800-635-5267
Manufacturer Reason
for Recall		 The internal speaker components are failing and do not produce an audio alarm in the event of patient emergency.
FDA Determined
Cause 2		 Other
Action Customers of record were notified of the advisory by letter sent via US Mail on October 18, 2004, via certified mail. A second letter was sent on December 9, 2004, advising customers that upgrades would be available. Upgrades would be available via returns to the firm''s service center, upgrade kits and speaker replacements via self-installation, and a third party service provider.
Quantity in Commerce 862 units
Distribution There are 2,950 Direct US and US territory Customers. Product shave also been distributed to Canada, Europe, Japan, Latin America and Australia.
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 = DQA and Original Applicant = NELLCOR PURITAN BENNETT, INC.
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