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Terminated

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

FDA Recall Z-1575-2014 · Posted 2014-05-09

Recall StatusTerminated
Product CodeOLO
Date Initiated2014-04-11
Date Terminated2014-06-10
Product Quantity11

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.

Firm 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].

Root Cause

Software design

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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