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Recall Observatory FDA recall evidence

Device product

The NAV3i Platform Power Box supplies the electrical components with power (e.g. Stryker Nav3 Graphite Camera, SPC-3 Computer, IO-Tablet (touch screen) and the monitor).

Z-1716-2014

May 13, 2014

Class II

Product summary

Firm
Stryker Instruments Div. of Stryker Corporation
Event
Event 68261
Status
Terminated
Classification
Class II
Quantity
20
Official record key
device-enforcement:Z-1716-2014

Official wording

Reason: The Stryker NAV3i Platform Power Boxes produced between December 9, 2013 and March 7, 2014 may have been assembled without electrical insulation of the soldering joints

Code information: Stryker Product Number: 7700-853-000 Stryker Serial Numbers: 10004

Distribution pattern: Distributed in the states of AR, CA, IN, LA, MA, MD, MI, MT, NV, and TX.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The Stryker NAV3i Platform Power Boxes produced between December 9, 2013 and March 7, 2014 may have been assembled without electrical insulation of the soldering joints