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Recall Observatory FDA recall evidence

Device 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.

Z-0350-2018

April 06, 2017

Class II

Product summary

Firm
Merge Healthcare, Inc.
Event
Event 76847
Status
Terminated
Classification
Class II
Quantity
1,150 power strips
Official record key
device-enforcement:Z-0350-2018

Official wording

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.

Code information: Part Number 04175-0008 and Part Number 13-00106-00

Distribution pattern: Nationwide.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.