Class 2 Device Recall Philips Lifeline

• Date Initiated by Firm: September 11, 2009
• Date Posted: November 25, 2009
• Recall Status: Terminated 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
• FEI Number: 3007138625
• 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: 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