Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0419-2010

Philips Lifeline Personal Help Button Pendant Classic and Slimline Style

Philips Lifeline Inc / initiated 2009-09-11 / Terminated

Philips Lifeline Inc began a recall of Philips Lifeline Personal Help Button Pendant Classic and Slimline Style on . The reason FDA records is "Pendant Personal Help Button neck cord may not break away and if not will present a potential choking risk". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0419-2010
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Philips Lifeline Inc
Product
Philips Lifeline Personal Help Button Pendant Classic and Slimline Style.
Product code
ILQ System, Communication, Powered
Reason for recall
Pendant Personal Help Button neck cord may not break away and if not will present a potential choking risk.
FDA 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 in commerce
715,000
Distribution
Nationwide Canada
Product codes and lots
All serial numbers