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
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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
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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 |
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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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