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Recall Observatory FDA recall evidence

Device product

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

Z-1316-2018

November 13, 2017

Class II

Product summary

Firm
Lifeline Systems Company
Event
Event 79010
Status
Terminated
Classification
Class II
Quantity
20201
Official record key
device-enforcement:Z-1316-2018

Official wording

Reason: 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

Derived failure modes

  • 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.