Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1996-2019Class II

STANLEY Healthcare Arial 54315 Network Manager

Securitas Healthcare LLC / initiated 2019-06-14 / Terminated

Stanley Security Solutions Inc began a recall of STANLEY Healthcare Arial 54315 Network Manager on . FDA classified it as Class II and gives the reason as "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". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-1996-2019
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Securitas Healthcare LLC
Product
STANLEY Healthcare Arial 54315 Network Manager
Product code
IQA System, Environmental Control, Powered
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 root cause
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
Product codes and lots
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

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1996-2019
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1996-2019Class IITerminatedVoluntary: Firm initiated