FDA Enforcement
Class II
Ongoing
Senior Living Arial Emergency and Nurse Call Systems
Recall: Z-0497-2022
·
Reported January 26, 2022
Enforcement
- Recall Number
- Z-0497-2022
- Event ID
- 89181
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Stanley Security Solutions Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 26, 2022
- Initiation Date
- November 17, 2021
- Classification Date
- January 14, 2022
- Address
- 4600 Vine St, N/A, Lincoln, NE, 68503-2823, United States
Description
Senior Living Arial Emergency and Nurse Call Systems
Reason
Systems are not alarming due to increased memory consumption.
Code Info
Model No. 0900-989; Lot No.: 7VQYZB3, G1GG8B3, 1TX2613, 7VQWZB3, GRRT243, 1TX3613, G1H58B3, HJP7N23, HJP9N23, 51SDR33, and GRRV243; UDI No.: (01)00840948100987(21)7VQYZB3, (01)00840948100987(21)1TX2613, (01)00840948100987(21)7VQZZB3, (01)00840948100987(21)GRRT243, (01)00840948100987(21)G1GF8B3, (01)00840948100987(21)1TX3613, (01)00840948100987(21)G1H58B3, (01)00840948100987(21)HJP7N23, (01)00840948100987(21)HJP9N23, (01)00840948100987(21)51SDR33, (01)00840948100987(21)GRRV243
Distribution
Worldwide distribution - US Nationwide distribution in the states of FL, MD, MI, MN, SD, TN, and WA. The countries of Canada and Qatar.
Quantity
11 units (systems)