FDA Medical Device Recalls (openFDA)
Securitas Healthcare LLC: Arial Water Resistant Pendant with Neck Lanyard, Models: 59360 and 2560-59360; mobile patient alarm
- Recall number
- Z-0220-2024
- Recalling firm
- Securitas Healthcare LLC
- Product
- Arial Water Resistant Pendant with Neck Lanyard, Models: 59360 and 2560-59360; mobile patient alarm
- Status
- Open, Classified
- Initiated
- 2023-09-25
- Posted
- 2023-11-03
- Terminated
- not on file
- Reason
- Premature battery depletion presents a risk that alarms will not be received by the Arial Wireless Emergency Call System.
- 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
- 1235 units
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
- Lot, serial or model codes
- Manufacturing date codes: 23128 to 23251
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- IQA
- Firm FEI
- 1929691
- Firm city
- Lincoln
- Firm state
- NE
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28