Arial Water Resistant Pendant with Neck Lanyard, Models: 59360 and 2560-59360; mobile patient alarm

FDA device recall Z-0220-2024 · posted 2023-11-03 · Open, Classified

Recall details

Recalling firm

Securitas Healthcare LLC

Reason for recall

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

Action taken

Securitas Healthcare issued a recall notice to its consignees on 09/25/2023 via USPS, registered mail. The notice explained the issue, potential hazard, and requested the following actions: 1. Immediately replace Pendant battery upon Low Battery Alert 2. Customer should check Pendant battery status in Arial System application at least daily 3. Customer should check for Pendants that are no longer communicating with the Arial System at least daily This notice must be passed on to those who need to be aware within your organization. - Securitas Healthcare will be replacing all Pendants from the Affected Lots with refurbished Pendants at no cost. The notice has also been posted: https://www.securitashealthcare.com/product-advisories

Root cause

Component change control

Status

Open, Classified

Product code

IQA

Quantity affected

1235 units

Distribution

Worldwide distribution - US Nationwide and the country of Canada.

Date initiated

2023-09-25

Date posted

2023-11-03

Location

Lincoln, NE