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Recall Observatory FDA recall evidence

Device product

Neurotherm NT2000iX RF Generator Model Number: RFG-NT -2000iX

Z-1361-2016

October 09, 2013

Class II

Product summary

Firm
Neurotherm, Inc.
Event
Event 73410
Status
Terminated
Classification
Class II
Quantity
25
Official record key
device-enforcement:Z-1361-2016

Official wording

Reason: NT2000iX software shipped with the international setting turned on. The international settings include access to Corodotomy, Bi-Polar, and No Temperature modes were not cleared in the United States for use.

Code information: Serial Numbers: 2593-13, 2717-13, 2616-13, 2704-13, 2735-13, 2360-12, 2732-13, 2727-13, 2284-11, 2726-13, 2728-13, 2426-12, 2700-13, 2508-12, 2643-13, 2733-13, 2730-13, 2724-13, 2453-12, 2631-13, 2171-11, 2059-10, 2729-13 ,2294-12, 2725-13

Distribution pattern: CA, CO, IA, ME, NJ, NY, SC, TX, WI

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    NT2000iX software shipped with the international setting turned on. The international settings include access to Corodotomy, Bi-Polar, and No Temperature modes were not cleared in the United States for use.