—#152105

Product

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

FDA product code: OUG — Medical Device Data System
Device class: Class 1
Medical specialty: General Hospital
Affected lot / code info: InfiniBand cables shipped between June 22, 2016 and October 6, 2016 in use with the Cisco 3850 switch.

Why it was recalled

May experience a loss of centralized monitoring.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Philips Electronics North America Corporation
Address: 3000 Minuteman Rd, Andover, Massachusetts 01810-1032

Distribution

Distribution pattern: 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

Timeline

Recall initiated: 2016-12-27
Terminated: 2020-10-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #152105. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.