Recall Z-1316-2018 ยท ILQ System, Communication, Powered
Lifeline Systems Company
HomeSafe AutoAlert Pendant works in conjunction with a compatible Lifeline communicator.
| Date | Nov 13, 2017 |
| Status | Terminated |
| 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 |
| 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 |