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U.S. Department of Health and Human Services

Class 2 Device Recall Securitas Healthcare Arial

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  Class 2 Device Recall Securitas Healthcare Arial see related information
Date Initiated by Firm September 25, 2023
Date Posted November 03, 2023
Recall Status1 Open3, Classified
Recall Number Z-0220-2024
Recall Event ID 93188
Product Classification System, environmental control, powered - Product Code IQA
Product Arial Water Resistant Pendant with Neck Lanyard, Models: 59360 and 2560-59360; mobile patient alarm
Code Information Manufacturing date codes: 23128 to 23251
Recalling Firm/
Manufacturer		 Securitas Healthcare LLC
4600 Vine St
Lincoln NE 68503-2823
For Additional Information Contact Ameya Oke
812-371-7115
Manufacturer Reason
for Recall		 Premature battery depletion presents a risk that alarms will not be received by the Arial Wireless Emergency Call System.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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