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U.S. Department of Health and Human Services

Class 2 Device Recall NavioPFSTM System

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  Class 2 Device Recall NavioPFSTM System see related information
Date Initiated by Firm April 11, 2014
Date Posted May 09, 2014
Recall Status1 Terminated 3 on June 10, 2014
Recall Number Z-1575-2014
Recall Event ID 68015
510(K)Number K121936  
Product Classification Orthopedic Sterotaxic Instrument - Product Code OLO
Product NavioPFSTM System, Orthopedic Sterotaxic Instrument, model #'s NPFS-02000, NPFS-02010, NPFS 02020.
Code Information SN000090, SN000091, SN000092, SN000187, SN000200, SN000204, SN000226, SN000231, SN000232, SN000246, SN000247
Recalling Firm/
Manufacturer		 Blue Belt Technologies MN
2905 Northwest Blvd Ste 40
Plymouth MN 55441-2673
For Additional Information Contact Customer Support
763-452-4922
Manufacturer 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.
FDA Determined
Cause 2		 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) lbrink@bluebelttech.com. 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, rlethbridge@bluebelttech.com.
Quantity in Commerce 11
Distribution USA: CA, PA, OH, TX. OUS: BELGIUM, SCOTLAND, UNITED KINGDOM.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = OLO and Original Applicant = BLUE BELT TECHNOLOGIES, INC.
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