FDA-Device2014-05-21Class II
NavioPFSTM System, Orthopedic Sterotaxic Instrument, model #'s NPFS-02000, NPFS-02010, NPFS 02020.
Blue Belt Technologies MN
Hazard
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.
Sold states
USA: CA, PA, OH, TX. OUS: BELGIUM, SCOTLAND, UNITED KINGDOM.
Affected count
11
Manufactured in
2905 Northwest Blvd Ste 40, Plymouth, MN, United States
Products
NavioPFSTM System, Orthopedic Sterotaxic Instrument, model #'s NPFS-02000, NPFS-02010, NPFS 02020.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1575-2014Don't want to check this manually?
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