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Medtronic Navigation, Inc. recalls Medtronic O-arm Imaging System Mobile X-ray system. Model No. BI-700-00027 and BI-700-00028 The 0-arm Imaging System
Recalled March 12, 2014 · FDA recall Z-0973-2014 · Medtronic Navigation
Hazard
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 Class II
Units
449 in US
Sold at
USA (nationwide) Distribution
Description
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)
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.
Manufacturer(s)
Medtronic Navigation, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →