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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 79010

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
November 13, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Lifeline Systems Company

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Z-1316-2018
Recall number
Z-1316-2018
Initiated
November 13, 2017
Classification
Class II
Status
Terminated
Recalling firm
Lifeline Systems Company
Quantity
20201

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A programing error in some Model FD100 HomeSafe AutoAlert Pendants will render the fall detection feature inoperable.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software Manufacturing/Software Deployment

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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.

Distribution pattern

US and Canada distribution