Blue Belt Technologies Recalls Navio PFS Orthopedic Sterotaxic Instrument
Blue Belt Technologies is voluntarily recalling 11 Navio PFS systems used in orthopedic knee surgery due to a potential electronic module defect that could cause latent failure.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a potential defect that could result in latent failure during surgery. Per the rubric, this is classified as High (3) because it is a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Blue Belt Technologies is conducting a voluntary recall of 11 units of the Navio PFS System, an orthopedic sterotaxic instrument used during orthopedic knee surgery. The affected models are NPFS-02000, NPFS-02010, and NPFS 02020.
The recall is being issued because one of the electronic modules inside the computer cart assembly may have a defect in one of its components. This defect could result in a latent failure of the system. The affected units were distributed in the United States (California, Pennsylvania, Ohio, Texas) and internationally (Belgium, Scotland, United Kingdom).
Healthcare facilities and consumers should stop using the affected Navio PFS systems immediately and contact Blue Belt Technologies for further instructions on the recall process.
The recalled product
- Product
- NavioPFSTM System, Orthopedic Sterotaxic Instrument, model #'s NPFS-02000, NPFS-02010, NPFS 02020.
- Manufacturer
- Blue Belt Technologies MN
- Affected units
- 11
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (11)
- SN000090
- SN000091
- SN000092
- SN000187
- SN000200
- SN000204
- SN000226
- SN000231
- SN000232
- SN000246
- SN000247
Distribution
Related recalls
Same manufacturer · Blue Belt Technologies MN
See all →- ModerateBlue Belt Technologies Recalls Mislabeled Stride Unicondylar Knee Prosthesis Components
FDA (Devices) · 2014-07-09
- ModerateBlue Belt Technologies Recalls Mislabeled Stride Femoral Knee Components
FDA (Devices) · 2014-07-09
- HighBlue Belt Technologies Recalls Sterile Monitor Drapes for Navio PFS System
FDA (Devices) · 2013-08-28
Same hazard · electronic defect
See all →- SevereMaquet CS 100 Intra-Aortic Balloon Pump Recalled for Electronic Defects
FDA (Devices) · 2017-09-13
- HighLaerdal Compact Suction Unit 4 Recalled for Electronic Component Damage
FDA (Devices) · 2017-04-26
Similar recalls
- HighBlue Belt Technologies Recalls Sterile Monitor Drapes for Navio PFS System
FDA (Devices) · 2013-08-28
- ModerateZimmer CAS Recalls Navitrack System Knee Instrument Due to Software Anomalies
FDA (Devices) · 2017-05-24
- ModerateZimmer CAS Recalls Navitrack System OS Knee Universal Software
FDA (Devices) · 2017-05-24
- HighFDA Recalls 84 Zimmer CAS SmartTools Knee System Instruments
FDA (Devices) · 2017-04-26
- HighPhilips Digital Diagnost Radiographic System Recall Due to Footboard Defect
FDA (Devices) · 2014-04-30
- ModerateBlue Belt Technologies Recalls Mislabeled Stride Femoral Knee Components
FDA (Devices) · 2014-07-09