NavioPFSTM System — Class II medical device recall Z-1575-2014
Terminated recall by Blue Belt Technologies MN, reported 2014-05-21, distributed in CA, OH, PA, TX. Blue Belt Technologies is conducting a voluntary recall for their Navio PFS system which is used during orthop
| Recall number | Z-1575-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Blue Belt Technologies MN, Plymouth, MN, United States |
| Recall initiated | 2014-04-11 |
| Classified | 2014-05-09 |
| Reported by FDA | 2014-05-21 |
| Terminated | 2014-06-10 |
| Distributed | CA, OH, PA, TX |
| Countries outside the US | BE, GB |
| Quantity | 11 |
| Model numbers | NPFS-02000, NPFS-02010 |
Product
NavioPFSTM System, Orthopedic Sterotaxic Instrument, model #'s NPFS-02000, NPFS-02010, NPFS 02020.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1575-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.