Z-0220-2024Class II

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

Name: Z-0220-2024 Arial Water Resistant Pendant with Neck Lanyard, Models: 59360 and 2560-59360; mobile patient alarm
Creator: Securitas Healthcare LLC
Published: 2023-09-25
License: https://open.fda.gov/license/

Securitas Healthcare LLC / initiated 2023-09-25 / Open, Classified

FDA source

Securitas Healthcare LLC began a recall of Arial Water Resistant Pendant with Neck Lanyard, Models: 59360 and 2560-59360; mobile patient alarm on 2023-09-25. FDA classified it as Class II and gives the reason as "Premature battery depletion presents a risk that alarms will not be received by the Arial Wireless Emergency Call System". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0220-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-09-25
Posted: 2023-11-03
Recalling firm: Securitas Healthcare LLC
Product: Arial Water Resistant Pendant with Neck Lanyard, Models: 59360 and 2560-59360; mobile patient alarm
Product code: IQA System, Environmental Control, Powered
Reason for recall: Premature battery depletion presents a risk that alarms will not be received by the Arial Wireless Emergency Call System.
FDA root cause: Component change control
Action: 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
Quantity in commerce: 1235 units
Distribution: Worldwide distribution - US Nationwide and the country of Canada.
Product codes and lots: Manufacturing date codes: 23128 to 23251

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0220-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0220-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-15	2023-11-03
Z-0221-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-15	2023-11-03
Z-0222-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-15	2023-11-03

Product code IQA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)