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U.S. Department of Health and Human Services

Class 2 Device Recall Fellows "Mighty 8" Power strip, TrippLite Power strip

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 Class 2 Device Recall Fellows "Mighty 8" Power strip, TrippLite Power stripsee related information
Date Initiated by FirmApril 06, 2017
Create DateJanuary 14, 2018
Recall Status1 Terminated 3 on July 10, 2019
Recall NumberZ-0350-2018
Recall Event ID 76847
510(K)NumberK152864 
Product Classification Computer, diagnostic, programmable - Product Code DQK
ProductFellows "Mighty 8" Power strip (Part Number 04175-0008) and TrippLite Power strip (PS-415-HGULTRA - Part Number 13-00106-00) are two components sold as part of the Merge Hemo System.
Code Information Part Number 04175-0008 and Part Number 13-00106-00
Recalling Firm/
Manufacturer		 Merge Healthcare, Inc.
900 Walnut Ridge Dr
Hartland WI 53029-8347
For Additional Information Contact
262-367-0700
Manufacturer Reason
for Recall		Merge is conducting a hardware recall (replacement) of Fellows "Mighty 8" Power Strip and TrippLite Power Strip due to overheat of input resistor causing the power strip to smoke.
FDA Determined
Cause 2		Component design/selection
ActionMerge began notify customers via an Urgent Medical Device Recall letter on 4/6/2017 via mail. The letter identified affected product, stated the issue, and informed customers that Merge would replace affected product. A response form is requested to be returned to Merge. Questions can be sent via email to recall@merge.com
Quantity in Commerce1,150 power strips
DistributionNationwide.
Total Product Life CycleTPLC 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.
510(K) Database510(K)s with Product Code = DQK
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