Recall Z-1575-2014 ยท OLO Orthopedic Stereotaxic Instrument
Blue Belt Technologies MN
NavioPFSTM System, Orthopedic Sterotaxic Instrument, model #'s NPFS-02000, NPFS-02010, NPFS 02020.
| Date | May 9, 2014 (initiated Apr 11, 2014) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 Eu |
| Quantity | 11 |
| Distribution | USA: CA, PA, OH, TX. OUS: BELGIUM, SCOTLAND, UNITED KINGDOM. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121936 | NAVIOPFS Blue Belt Technologies, Inc., Nov 30, 2012 |