Recall Z-0221-2024 ยท IQA System, Environmental Control, Powered
Securitas Healthcare LLC
Arial Water Resistant Pendant with Wristband, Models: 59361 and 2560-59361; mobile patient alarm
| Date | Nov 3, 2023 (initiated Sep 25, 2023) |
| Status | Open, Classified |
| 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 |
| Quantity | 2691 units |
| Distribution | Worldwide distribution - US Nationwide and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.