FDA Device recall Z-1316-2018
HomeSafe AutoAlert Pendant works in conjunction with a compatible Lifeline communicator
- FDA Device
- Class II
- terminated
- Published 2018-04-18
On 2018-04-18 the FDA classified a Class II recall of HomeSafe AutoAlert Pendant works in conjunction with a compatible Lifeline communicator by Lifeline Systems, citing A programing error in some Model FD100 HomeSafe AutoAlert Pendants will render the fall detection feature inoperable.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1316-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-11-13 |
| Published | 2018-04-18 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Lifeline Systems |
| Distribution | n/a |
Product
HomeSafe AutoAlert Pendant works in conjunction with a compatible Lifeline communicator.
Reason
A programing error in some Model FD100 HomeSafe AutoAlert Pendants will render the fall detection feature inoperable.
Identifiers
| code_info | Model FD100 HomeSafe AutoAlert Pendants with Reference Number 300000219841 and 300000219851 All materials with R an…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1316-2018%22
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