FDA Recall
Terminated
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.
Recall: Z-0350-2018
·
Initiated April 6, 2017
Recall
- Recall Number
- Z-0350-2018
- Event Number
- 76847
- Firm
- Merge Healthcare, Inc.
- FEI Number
- 1000116130
- Product Code
- DQK
- Status
- Terminated
- Root Cause
- Component design/selection
- Initiated
- April 6, 2017
- Terminated
- July 10, 2019
- Address
- 900 Walnut Ridge Dr, Hartland, WI, 53029-8347
Description
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.
Reason
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.
Action
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 [email protected]
Distribution
Nationwide.
Quantity
1,150 power strips