The Recall Desk
HighFDA (Devices)·Z-0221-2024·Announced 2023-11-15

Pendant Patient Alarm Battery Defect Prevents Emergency Alerts

Securitas Healthcare LLC recalls Arial Water Resistant Pendants (Models 59361 and 2560-59361) because premature battery depletion may prevent emergency alarms from reaching the wireless alert system. Affected patients may not receive emergency assistance when needed.

What this means for you

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: This is a Class II FDA recall of a risk-of-harm product—a patient emergency alarm device. No illnesses or injuries are reported, but the device malfunction creates the risk that patients cannot summon emergency assistance when needed. Per the rubric, this qualifies as a 'risk-of-harm product where injury has not yet been reported.'

Plain-English summary

Securitas Healthcare LLC is recalling Arial Water Resistant Pendants with Wristband, Models 59361 and 2560-59361. These are mobile patient alarm devices designed to transmit emergency alerts to a wireless call system. The recall affects approximately 2,691 units manufactured with date codes 23128 to 23251 and distributed in the United States nationwide and Canada.

Premature battery depletion in these devices presents a risk that emergency alarms will not be received by the Arial Wireless Emergency Call System.

Consumers with these devices should contact Securitas Healthcare LLC for information regarding this recall.

The recalled product

Product
Arial Water Resistant Pendant with Wristband, Models: 59361 and 2560-59361; mobile patient alarm
Manufacturer
Securitas Healthcare LLC
Hazard
  • battery-depletion
  • alarm-failure

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)

  • Manufacturing date codes: 23128 to 23251

Distribution

Distributed nationwide across the United States.