🔍 RecallPedia

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

Class I - Dangerous
🏥 Medical Devices Recalled: April 11, 2014 Blue Belt Technologies MN Surgical Instruments

What Should You Do?

  1. Check if you have this product:
    SN000090, SN000091, SN000092, SN000187, SN000200, SN000204, SN000226, SN000231, SN000232, SN000246, SN000247
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Blue Belt Technologies MN
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

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

Product Codes/Lot Numbers:

SN000090, SN000091, SN000092, SN000187, SN000200, SN000204, SN000226, SN000231, SN000232, SN000246, SN000247

Distribution:

Distributed in: CA, PA, OH, TX

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1575-2014

Related Recalls

Blue Belt Technologies, Inc. Monitor Drape REF: PFSD-V0001, Rx only, Sterile EO. Product Usage: The intended use of this device is t protect equipment from contamination during a variety of procedures throughout the clinical setting.

Blue Belt Technologies MN

Class I - Dangerous

Blue Belt Technologies is recalling sterile Monitor Drapes used with their Navio PFS system during orthopedic knee surgery. The drapes are used to cover the Navio PFS system computer monitor and arm assembly and provide a sterile barrier in the surgical suite. The defect is evident when the computer monitor is being draped. The front section of the drape separates from the rest of the drape at

Jul 19, 2013 Diagnostic Equipment Nationwide View Details →