Recall Z-0973-2014
Medtronic Navigation, Inc. · initiated July 25, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Model No. BI-700-00027 and BI-700-00028 Serial number range: 00102 through 00753 and B13080721, B13080722, B13090729, B13120763, B13120764, B13120766, B13120768, B13120769
Reason for recall
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)
FDA-determined cause: Radiation Control for Health and Safety Act
Action taken
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.
Details
- Recall number
- Z-0973-2014
- Initiated
- July 25, 2013
- Posted by FDA
- February 28, 2014
- Terminated
- April 17, 2019
- Product code
- OXO – Image-Intensified Fluoroscopic X-Ray System, Mobile
- Quantity
- 449 in US
- Distribution
- USA (nationwide) Distribution
- Recalling firm
- Medtronic Navigation, Inc., Littleton, MA