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U.S. Department of Health and Human Services

Class 2 Device Recall STANLEY Healthcare Arial 54315 Network Manager environmental control, powered

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  Class 2 Device Recall STANLEY Healthcare Arial 54315 Network Manager environmental control, powered see related information
Date Initiated by Firm June 14, 2019
Create Date July 19, 2019
Recall Status1 Terminated 3 on May 13, 2021
Recall Number Z-1996-2019
Recall Event ID 83266
Product Classification System, environmental control, powered - Product Code IQA
Product STANLEY Healthcare Arial 54315 Network Manager
Code Information Serial Numbers:  0008DC517FD2, 0008DC517FD3, 0008DC517FD4, 0008DC517FD5, 0008DC517FD6, 0008DC517FD7, 0008DC517FD8, 0008DC517FD9, 0008DC517FDA, 0008DC517FDB, 0008DC517FDC, 0008DC517FDD, 0008DC517FDE, 0008DC517FDF, 0008DC517FE0, 0008DC517FE1, 0008DC517FE2, 0008DC517FE3, 0008DC517FE4, 0008DC517FE5, 0008DC51807D, 0008DC51807E, 0008DC51807F, 0008DC518080, 0008DC518081, 0008DC518082, 0008DC518083, 0008DC518084, 0008DC518085, 0008DC518086, 0008DC56ECDA, 0008DC56ECDB, 0008DC56ECDC, 0008DC56ECDD, 0008DC56ECE1, 0008DC56ED32, 0008DC56ED33, 0008DC56ED37, 0008DC56ED38, 0008DC56ED39, 0008DC56ED3A, 0008DC56ED3B, 0008DC56ED3C, 0008DC56ED3D, 0008DC56ED56, 0008DC56ED57, 0008DC56ED58, 0008DC56ED5A, 0008DC56ED5B, 0008DC56ED5D, 0008DC56ED5F, 0008DC56ED60, 0008DC56ED61, 0008DC56ED66, 0008DC56ED67, 0008DC56ED68, 0008DC56ED69, 0008DC56ED6D, 0008DC56ED72, 0008DC56ED76, 0008DC56ED77, 0008DC56ED78, 0008DC56ED7A, 0008DC56ED7B, 0008DC56ED7C, 0008DC56ED7D, 0008DC56ED80, 0008DC56ED81, 0008DC56ED82, 0008DC56ED83, 0008DC56ED84, 0008DC56ED85, 0008DC56ED86, 0008DC56ED87, 0008DC56ED88, 0008DC56ED89, 0008DC56ED8A, 0008DC56ED8B, 0008DC56ED8C, 0008DC56ED8E, 0008DC56ED8F, 0008DC56ED90, 0008DC56ED91, 0008DC56ED92, 0008DC56ED93, 0008DC56ED94, 0008DC56ED98, 0008DC56ED99, 0008DC56ED9A, 0008DC56ED9E, 0008DC56EDA0, 0008DC56EDA1, 0008DC56EE26, 0008DC56EE2A, 0008DC56EE42, 0008DC56EE43, 0008DC56EE44, 0008DC56EE45, 0008DC56EE49, 0008DC56EE4A, 0008DC56EE4B, 0008DC56EE4E, 0008DC56EE4F, 0008DC56EE50, 0008DC56EE51, 0008DC56EE52, 0008DC56EE53, 0008DC56EE54, 0008DC56EE55, 0008DC56EE5A, 0008DC56EE5B, 0008DC56EE5C, 0008DC56EE60, 0008DC56EE61, 0008DC56EE6A, 0008DC56EE6B, 0008DC56EE6C, 0008DC56EE6E, 0008DC56EE6F, 0008DC56EE70, 0008DC56EE71, 0008DC56EE72, 0008DC56EE73, 0008DC56EE74, 0008DC56EE75, 0008DC56EE76, 0008DC56EE77, 0008DC56EE78, 0008DC56EE79, 0008DC56EE7A, 0008DC56EE7C, 0008DC56EE7D, 0008DC56EE7E, 0008DC56EE7F, 0008DC56EE80, 0008DC56EE81, 0008DC56EE82
Recalling Firm/
Manufacturer		 Stanley Security Solutions Inc
4600 Vine St
Lincoln NE 68503-2823
For Additional Information Contact Mr. Paul Hall
402-742-9419
Manufacturer Reason
for Recall		 STANLEY Healthcare has received reports of outages on the Arial nurse call system. These outages have been traced back to the Arial¿ 54315 Serial-to-IP Network Gateway.
FDA Determined
Cause 2		 Under Investigation by firm
Action The firm initiated the recall by email on 06/14/2019. The letter requests that all users that receive a Warning flag on an Arial computer immediately contact the Technical Support Department to provide assistance in troubleshooting. The firm will be distributing replacement units
Quantity in Commerce 137 units
Distribution Nationwide and 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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