Recall Z-0419-2010 ยท ILQ System, Communication, Powered
Philips Lifeline Inc
Philips Lifeline Personal Help Button Pendant Classic and Slimline Style.
| Date | Nov 25, 2009 (initiated Sep 11, 2009) |
| Status | Terminated |
| Reason | Pendant Personal Help Button neck cord may not break away and if not will present a potential choking risk. |
| Root 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 | 715,000 |
| Distribution | Nationwide Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K914103 | LIFELINE(R) PERSONAL RESPONSE SYSTEM Lifeline Systems, Inc., Sep 27, 1991 |