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Terminated

HomeSafe AutoAlert Pendant works in conjunction with a compatible Lifeline communicator.

FDA Recall Z-1316-2018 · Posted None

Recalling FirmLifeline Systems Company
Recall StatusTerminated
Product CodeILQ
Date Initiated2017-11-13
Date Terminated2019-05-16
Product Quantity20201

Reason for Recall

A programing error in some Model FD100 HomeSafe AutoAlert Pendants will render the fall detection feature inoperable.

Firm 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.

Root Cause

Software Manufacturing/Software Deployment

Distribution Pattern

US and Canada distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K914103LIFELINE(R) PERSONAL RESPONSE SYSTEMLifeline Systems, Inc. · 1991-09-27

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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