FDA Enforcement
Class II
Ongoing
Arial Call Station, Model Numbers CSK200-1069 and CSK200-1069MR, is a wireless nurse call station.
Recall: Z-2418-2024
·
Reported July 31, 2024
Enforcement
- Recall Number
- Z-2418-2024
- Event ID
- 94882
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Securitas Healthcare LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- July 31, 2024
- Initiation Date
- June 20, 2024
- Classification Date
- July 23, 2024
- Address
- 4600 Vine St, Lincoln, NE, 68503-2823, United States
Description
Arial Call Station, Model Numbers CSK200-1069 and CSK200-1069MR, is a wireless nurse call station.
Reason
This is a risk that alarms will not be received by the Arial Wireless Nurse Call System and premature depletion of the battery.
Code Info
All units of the Affected Device Models sold between July 26, 2022 and June 5, 2024
Distribution
US: FL, CA, AL, ND, MS, WA, MN, TX, OR, WI, MD, NY, NE
Quantity
77 units