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U.S. Department of Health and Human Services

Class 2 Device Recall Philips

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  Class 2 Device Recall Philips see related information
Date Initiated by Firm December 27, 2016
Create Date January 26, 2017
Recall Status1 Terminated 3 on October 08, 2020
Recall Number Z-1106-2017
Recall Event ID 76079
Product Classification Medical device data system - Product Code OUG
Product Philips Cisco 3850 layer 3 switch, 865339 model WS-C3850-12S-E in use with IntelliVue Information Center iX or Classic Information Center
Code Information InfiniBand cables shipped between June 22, 2016 and October 6, 2016 in use with the Cisco 3850 switch.
Recalling Firm/
Manufacturer		 Philips Electronics North America Corporation
3000 Minuteman Rd
Andover MA 01810-1032
For Additional Information Contact
800-722-9377
Manufacturer Reason
for Recall		 May experience a loss of centralized monitoring.
FDA Determined
Cause 2		 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
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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