Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0350-2018Class II

Fellows "Mighty 8" Power strip (Part Number 04175-0008) and TrippLite Power strip (PS-415-HGULTRA - Part...

Merge Healthcare Incorporated / initiated 2017-04-06 / Terminated / root cause: design

Merge Healthcare, Inc. began a recall of 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... on . FDA classified it as Class II and gives the reason as "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". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-0350-2018
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Merge Healthcare Incorporated
Product
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.
Product code
DQK Computer, Diagnostic, Programmable
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.
Root cause tag
design
FDA root cause
Component design/selection
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]
Quantity in commerce
1,150 power strips
Distribution
Nationwide.
Product codes and lots
Part Number 04175-0008 and Part Number 13-00106-00

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-0350-2018
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-0350-2018Class IITerminatedVoluntary: Firm initiated