Z-0497-2022 Class II Ongoing
FDA device recall Z-0497-2022 was initiated by Stanley Security Solutions Inc on November 17, 2021 and is designated Class II. Reason for recall: Systems are not alarming due to increased memory consumption. The recall status is ongoing. Affected quantity: 11 units (systems).
Recall Details
- Product Type
- Devices
- Report Date
- January 26, 2022
- Initiation Date
- November 17, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11 units (systems)
Product Description
Senior Living Arial Emergency and Nurse Call Systems
Reason for Recall
Systems are not alarming due to increased memory consumption.
Distribution Pattern
Worldwide distribution - US Nationwide distribution in the states of FL, MD, MI, MN, SD, TN, and WA. The countries of Canada and Qatar.
Code Information
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