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Terminated

Philips Lifeline Personal Help Button Pendant Classic and Slimline Style.

FDA Recall Z-0419-2010 · Posted 2009-11-25

Recalling FirmPhilips Lifeline Inc
Recall StatusTerminated
Product CodeILQ
Date Initiated2009-09-11
Date Terminated2012-10-02
Product Quantity715,000

Reason for Recall

Pendant Personal Help Button neck cord may not break away and if not will present a potential choking risk.

Firm 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

Root Cause

Other

Distribution Pattern

Nationwide Canada

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K914103LIFELINE(R) PERSONAL RESPONSE SYSTEMLifeline Systems, Inc. · 1991-09-27

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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