Z-1575-2014Class II

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

Name: Z-1575-2014 NavioPFSTM System, Orthopedic Sterotaxic Instrument, model #'s NPFS-02000, NPFS-02010, NPFS 02020
Creator: Blue Belt Technologies MN
Published: 2014-04-11
License: https://open.fda.gov/license/

Blue Belt Technologies MN / initiated 2014-04-11 / Terminated / root cause: software

FDA source

Blue Belt Technologies MN began a recall of NavioPFSTM System, Orthopedic Sterotaxic Instrument, model #'s NPFS-02000, NPFS-02010, NPFS 02020 on 2014-04-11. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1575-2014
Classification: Class II
Status: Terminated
Initiated: 2014-04-11
Posted: 2014-05-09
Terminated: 2014-06-10
Recalling firm: Blue Belt Technologies MN
Product: NavioPFSTM System, Orthopedic Sterotaxic Instrument, model #'s NPFS-02000, NPFS-02010, NPFS 02020.
Product code: OLO Orthopedic Stereotaxic Instrument
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.
Root cause tag: software
FDA root cause: Software design
Action: Beginning April 3, 2014 consignees were hand delivered a Blue Belt Technologies, Inc. "Urgent Medical Device Recall" letter. The letter was addressed to Safety Officer / Regulatory Compliance Officer. The letter included the Description of the Issue, Description of Safety Concerns, Affected Product, Action to be taken by user, Transmission of this field safety notice and Contacts at Blue Belt Technologies. For questions in the USA contact Customer Support Blue Belt Technologies 2900 Northwest Blvd, Suite 40, Plymouth, MN 55441, USA, 1-763-452-4922 (Direct) [email protected]. In the European Union, Ross Lethbridge, European Product Manager, Blue Belt Technologies, Office number 207, 3000 Aviator Way. Manchester Business Park, Manchester, UK M22 5TG, Mobile: +44 7787 415069, [email protected].
Quantity in commerce: 11
Distribution: USA: CA, PA, OH, TX. OUS: BELGIUM, SCOTLAND, UNITED KINGDOM.
Product codes and lots: SN000090, SN000091, SN000092, SN000187, SN000200, SN000204, SN000226, SN000231, SN000232, SN000246, SN000247

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1575-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1575-2014	Class II	Terminated	Voluntary: Firm initiated	2014-05-21	2014-05-09

Product code OLO

K121936Class IINaviopfsBlue Belt Technologies, Inc. / cleared 2012-11-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)