510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
Manufacturing
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Z-1106-2017Class II

Philips Cisco 3850 layer 3 switch, 865339 model WS-C3850-12S-E in use with IntelliVue Information Center iX...

Philips North America LLC / initiated 2016-12-27 / Terminated

Philips Electronics North America Corporation began a recall of Philips Cisco 3850 layer 3 switch, 865339 model WS-C3850-12S-E in use with IntelliVue Information Center iX or Classic Information Center on . FDA classified it as Class II and gives the reason as "May experience a loss of centralized monitoring". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-1106-2017
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Philips North America LLC
Product
Philips Cisco 3850 layer 3 switch, 865339 model WS-C3850-12S-E in use with IntelliVue Information Center iX or Classic Information Center
Product code
OUG Medical Device Data System
Reason for recall
May experience a loss of centralized monitoring.
FDA root cause
Under Investigation by firm
Action
Philips sent an Field Safety Notice on December 27, 2016, to customers via certified mail. The notice explains the issue and informs the customers that no actions are required. The product may be used until the replacement cable is made available. If you need any further information or support concerning this issue, please call your local Philips Representative at (800) 722-9377.
Quantity in commerce
107
Distribution
Worldwide Distribution - US Distribution to the states of : AK CA CO FL GA KY NC NE NH NJ NY OH PA SC TN TX VA WA and WV., and to the countries of : Canada, Germany, Japan, New Zealand, Poland and United Kingdom
Product codes and lots
InfiniBand cables shipped between June 22, 2016 and October 6, 2016 in use with the Cisco 3850 switch.

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1106-2017
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1106-2017Class IITerminatedVoluntary: Firm initiated