Recall Z-0973-2014 ยท OXO Image-Intensified Fluoroscopic X-Ray System, Mobile
Medtronic Navigation, Inc.
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 i
| Date | Feb 28, 2014 (initiated Jul 25, 2013) |
| Status | Terminated |
| Reason | 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 | Radiation Control for Health and Safety Act |
| Action | 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 |
| Quantity | 449 in US |
| Distribution | USA (nationwide) Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K092564 | O-ARM IMAGING SYSTEM Medtronic Navigation, Inc. (Littleton), Jun 17, 2010 |