Philips Lifeline Personal Help Button Pendant Classic and Slimline Style.
FDA device recall Z-0419-2010 · posted 2009-11-25 · Terminated
Recall details
- Recalling firm
- Philips Lifeline Inc
- Reason for recall
- Pendant Personal Help Button neck cord may not break away and if not will present a potential choking risk.
- Action taken
- 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
- Status
- Terminated
- Product code
- ILQ
- Quantity affected
- 715,000
- Distribution
- Nationwide Canada
- Date initiated
- 2009-09-11
- Date posted
- 2009-11-25
- Date terminated
- 2012-10-02
- Location
- Framingham, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LIFELINE(R) PERSONAL RESPONSE SYSTEM (K914103) | Lifeline Systems, Inc. | 1991-09-27 |