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Recall Observatory FDA recall evidence

Device product

NavioPFSTM System, Orthopedic Sterotaxic Instrument, model #'s NPFS-02000, NPFS-02010, NPFS 02020.

Z-1575-2014

April 11, 2014

Class II

Product summary

Firm
Blue Belt Technologies MN
Event
Event 68015
Status
Terminated
Classification
Class II
Quantity
11
Official record key
device-enforcement:Z-1575-2014

Official wording

Reason: Blue Belt Technologies is conducting a voluntary recall for their Navio PFS system which is used during orthopedic knee surgery. One of the electronic modules inside the computer cart assembly may have a defect in one of its components that could result in a latent failure.

Code information: SN000090, SN000091, SN000092, SN000187, SN000200, SN000204, SN000226, SN000231, SN000232, SN000246, SN000247

Distribution pattern: USA: CA, PA, OH, TX. OUS: BELGIUM, SCOTLAND, UNITED KINGDOM.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Blue Belt Technologies is conducting a voluntary recall for their Navio PFS system which is used during orthopedic knee surgery. One of the electronic modules inside the computer cart assembly may have a defect in one of its components that could result in a latent failure.