HomeSafe AutoAlert Pendant works in conjunction with a compatible… — Class II medical device recall Z-1316-2018
Terminated recall by Lifeline Systems Company, reported 2018-04-18. A programing error in some Model FD100 HomeSafe AutoAlert Pendants will render the fall detection feature inop
| Recall number | Z-1316-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Lifeline Systems Company, Framingham, MA, United States |
| Recall initiated | 2017-11-13 |
| Classified | 2018-04-06 |
| Reported by FDA | 2018-04-18 |
| Terminated | 2019-05-16 |
| Countries outside the US | CA |
| Quantity | 20,201 |
| Model numbers | FD100 |
Product
HomeSafe AutoAlert Pendant works in conjunction with a compatible Lifeline communicator.
Reason for recall
A programing error in some Model FD100 HomeSafe AutoAlert Pendants will render the fall detection feature inoperable.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1316-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.