—#125338

Product

Medtronic O-arm Imaging System Mobile X-ray system. Model No. BI-700-00027 and BI-700-00028 The 0-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from 2D and 3D information of anatomic structures and objects with high x-ray attenuation such as bony anatomy and metallic objects. The 0-ann Imaging System is compatible with certain Image Guided Surgery Systems.

FDA product code: OXO — Image-Intensified Fluoroscopic X-Ray System, Mobile
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K092564
Affected lot / code info: Model No. BI-700-00027 and BI-700-00028 Serial number range: 00102 through 00753 and B13080721, B13080722, B13090729, B13120763, B13120764, B13120766, B13120768, B13120769

Why it was recalled

Review of on-system electronic product labeling and Instructions for comply with applicable Use in response to a customer inquiry uncovered gaps in compliance FDA standards with the requirements for information to be provided to users in 21CFR 1020.30(h)

Root cause (FDA determination)

Radiation Control for Health and Safety Act

Action the firm took

Medtronic Navigation Inc. issued Notiifcation on 3/4/14 and included thee errata sheet to all affected customers updating the missing and incorrect information and ensure that labeling is now in compliance with 21 CFR Part 1020.30(h). This will be followed by a software update that contains the same information on the errata sheet, which serves to correct the electronic version of the Instructions for Use. The paper errata sheet will be sent via traceable means and the software upgrade will be performed by Medtronic Service either through remote access or by site visit of Medtronic service personnel. For further questions please call (978) 698-6000.

Recalling firm

Firm: Medtronic Navigation, Inc.
Address: 300 Foster St, Littleton, Massachusetts 01460-2017

Distribution

Distribution pattern: USA (nationwide) Distribution

Timeline

Recall initiated: 2013-07-25
Posted by FDA: 2014-02-28
Terminated: 2019-04-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #125338. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.