Lifeline HomeSafe AutoAlert Pendant Recall for Fall Detection Error
Lifeline Systems is recalling Model FD100 HomeSafe AutoAlert Pendants because a programming error disables the fall detection feature.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where a safety feature (fall detection) is inoperable, posing a risk of harm if a fall occurs, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Lifeline Systems Company is recalling specific Model FD100 HomeSafe AutoAlert Pendants. These pendants are designed to work with a compatible Lifeline communicator to provide emergency assistance.
The recall is due to a programming error that renders the fall detection feature inoperable. This means the device may not detect a fall or trigger an alert as intended.
The affected units are Model FD100 HomeSafe AutoAlert Pendants with Reference Numbers 300000219841 and 300000219851. The recall includes all materials with R and UR prefixes that were remanufactured between July 28, 2017, and November 6, 2017. The products were distributed in the US and Canada. Consumers should stop using the fall detection feature and contact Lifeline Systems for instructions on repair or replacement.
The recalled product
- Product
- HomeSafe AutoAlert Pendant works in conjunction with a compatible Lifeline communicator.
- Manufacturer
- Lifeline Systems Company
- Hazard
- Affected units
- 20,201
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 100% of this material (UDI) are affected.
Distribution
Distribution scope not specified by the agency.
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- Severe