Blue Belt Technologies MN: Medical Device Recall in 2014 - (Recall #: Z-1575-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: April 11, 2014

Date Posted: May 21, 2014

Recall Number: Z-1575-2014

Event ID: 68015

Reason for Recall:

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.

Status: Terminated

Product Quantity: 11

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.

Voluntary or Mandated:

Voluntary: Firm initiated