FDA Medical Device Recalls (openFDA)
Lifeline Systems Company: HomeSafe AutoAlert Pendant works in conjunction with a compatible Lifeline communicator.
- Recall number
- Z-1316-2018
- Recalling firm
- Lifeline Systems Company
- Product
- HomeSafe AutoAlert Pendant works in conjunction with a compatible Lifeline communicator.
- Status
- Terminated
- Initiated
- 2017-11-13
- Posted
- not on file
- Terminated
- 2019-05-16
- Reason
- A programing error in some Model FD100 HomeSafe AutoAlert Pendants will render the fall detection feature inoperable.
- Root cause
- Software Manufacturing/Software Deployment
- Action
- Firm has contacted all recipients and informed them of an issue that affects Philips Lifeline AutoAlert help button from automatically signaling the Lifeline Response Center for help in the event of a fall. Further instructed them that they would need to press the Lifeline Help Button in order to connect with the emergency response center. They then instruct them to return their inventory for replacement. New AAHB Replacements will be provided when available. Philips will work with the Programs to ensure buttons swaps are completed.
- Quantity
- 20201
- Distribution
- US and Canada distribution
- Lot, serial or model codes
- Model FD100 HomeSafe AutoAlert Pendants with Reference Number 300000219841 and 300000219851 All materials with R and UR prefixes remanufactured between 07-28 -2017 and 1 1-06-20 17; 100% of this material (UDI) are affected.
- 510(k) numbers
- ["K914103"]
- PMA numbers
- not on file
- Product code
- ILQ
- Firm FEI
- 1000086682
- 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
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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