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U.S. Department of Health and Human Services

Class 2 Device Recall Philips Lifeline

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  Class 2 Device Recall Philips Lifeline see related information
Date Initiated by Firm September 11, 2009
Date Posted November 25, 2009
Recall Status1 Terminated 3 on October 02, 2012
Recall Number Z-0419-2010
Recall Event ID 53261
510(K)Number k914103  
Product Classification System, Communication, Powered - Product Code ILQ
Product Philips Lifeline Personal Help Button Pendant Classic and Slimline Style.
Code Information All serial numbers
Recalling Firm/
Manufacturer		 Philips Lifeline Inc
111 Lawrence St
Framingham MA 01702-8156
Manufacturer Reason
for Recall		 Pendant Personal Help Button neck cord may not break away and if not will present a potential choking risk.
FDA Determined
Cause 2		 Other
Action Philips Lifeline initiated Safety Notification letters on 9/21/09 to users and advised of the potential choking risk of the Pendant Personal Help Button The firm recommends that users consult their health care providers to determine which style of emergency button, including those that are worn on the wrist, is most beneficial for them. A postage-paid reply envelope had been provided. Questions should be addressed to Philips at 1-877-221-8756 (Monday  Friday, 8 a.m.  8 p.m. EST). Firm issued Press on 9/11/09. FDA Press issued 9/22/09
Quantity in Commerce 715,000
Distribution Nationwide Canada
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 = ILQ and Original Applicant = LIFELINE SYSTEMS, INC.
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