Home / Recalls / Medical Devices
Blue Belt Technologies MN recalls NavioPFSTM System, Orthopedic Sterotaxic Instrument, model #'s NPFS-02000, NPFS-02010, NPFS 02020.
Recalled May 21, 2014 · FDA recall Z-1575-2014 · 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. · FDA Class II
Units
11
Sold at
USA: CA, PA, OH, TX. OUS: BELGIUM, SCOTLAND, UNITED KINGDOM.
Description
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.
Product
NavioPFSTM System, Orthopedic Sterotaxic Instrument, model #'s NPFS-02000, NPFS-02010, NPFS 02020.
Manufacturer(s)
Blue Belt Technologies MN
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →