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.
Enforcement
- Recall Number
- Z-0973-2014
- Event ID
- 67363
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Medtronic Navigation, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- March 12, 2014
- Initiation Date
- July 25, 2013
- Classification Date
- February 28, 2014
- Termination Date
- April 17, 2019
- Address
- 300 Foster St, Littleton, MA, 01460-2017, United States
Description
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.
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)
Model No. BI-700-00027 and BI-700-00028 Serial number range: 00102 through 00753 and B13080721, B13080722, B13090729, B13120763, B13120764, B13120766, B13120768, B13120769
USA (nationwide) Distribution
449 in US