FDA Medical Device Recalls (openFDA)
Philips Lifeline Inc: Philips Lifeline Personal Help Button Pendant Classic and Slimline Style.
- Recall number
- Z-0419-2010
- Recalling firm
- Philips Lifeline Inc
- Product
- Philips Lifeline Personal Help Button Pendant Classic and Slimline Style.
- Status
- Terminated
- Initiated
- 2009-09-11
- Posted
- 2009-11-25
- Terminated
- 2012-10-02
- 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
- Lot, serial or model codes
- All serial numbers
- 510(k) numbers
- ["K914103"]
- PMA numbers
- not on file
- Product code
- ILQ
- Firm FEI
- 3007138625
- Firm city
- Framingham
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28