NavioPFSTM System, Orthopedic Sterotaxic Instrument, model #'s NPFS-02000, NPFS-02010, NPFS 02020.
FDA device recall Z-1575-2014 · posted 2014-05-09 · Terminated
Recall details
- Recalling firm
- 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.
- Action taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- OLO
- Quantity affected
- 11
- Distribution
- USA: CA, PA, OH, TX. OUS: BELGIUM, SCOTLAND, UNITED KINGDOM.
- Date initiated
- 2014-04-11
- Date posted
- 2014-05-09
- Date terminated
- 2014-06-10
- Location
- Plymouth, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NAVIOPFS (K121936) | Blue Belt Technologies, Inc. | 2012-11-30 |