FDAClass IIApril 18, 2018

HomeSafe AutoAlert Pendant works in conjunction with a recall

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

Why was HomeSafe AutoAlert Pendant works in conjunction with a recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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.

Product
HomeSafe AutoAlert Pendant works in conjunction with a compatible Lifeline communicator.
Recalling firm
Lifeline Systems Company
Quantity
20201
Distribution
US and Canada distribution
Recall date
April 18, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
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