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Recall Observatory FDA recall evidence

Device product

The Stryker NAV3i Platform is a mobile cart platform consisting of the sub-components Stryker Nav3 Graphite Camera, SPC-3 Computer and IO-Tablet (touch screen) as well as the monitor, articulated arms and cart housing. This Navigation system is used in combination with surgical software for cranial, spine, ENT, orthopedic and trauma procedures.

Z-1715-2014

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-1715-2014

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: 7700-800-000 Stryker Serial Numbers: 15097, 15098, 15099, 15102, 15103, 15104, 15105, 15106, 15107, 15109, 15110, 15111, 15112, 15113, 15114, 15115, 15116, 15117, 15118

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