Fellows "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.
This recall has been terminated (originally issued April 6, 2017).
- Company
- Merge Healthcare, Inc.
- Recall Initiated
- April 6, 2017
- Terminated
- July 10, 2019
- Recall Number
- Z-0350-2018
- Quantity
- 1,150 power strips
- Firm Location
- Hartland, WI
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide.
Lot / Code Info
Part Number 04175-0008 and Part Number 13-00106-00
Root Cause
Component design/selection
Action Taken
Merge 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
More recalls by Merge Healthcare, Inc.
Merge Hemo, Model RCSV2, Model/Catalog Number 99-01172-00, software versions 11.1 and 11.1.1
Product...
Sep 4, 2025
VERICIS, Merge Cardio, Model/Catalog Number: Version 12.X, Software Version: 12.0.1, 12.0.2; The VER...
Mar 20, 2025
VERICIS, Merge Cardio, Model/Catalog Number: Version 11.x, Software Version: 11.0.2, 11.0.3, 11.0.4,...
Mar 20, 2025