FDA-Device2016-07-13Class II

Medtronic 0-arm Imaging mobile x-ray system. Model Numbers - B1-700-00027, B1-700-00028

Medtronic Navigation, Inc.-Littleton
Hazard

It has been discovered that replacement x-ray generator and system motion batteries could become damaged during shipment, resulting in unacceptable risk of failure.

Sold states
Nationwide Distribution
Affected count
US - 581
Manufactured in
300 Foster Street, N/A, Littleton, MA, United States
Products
Medtronic 0-arm Imaging mobile x-ray system. Model Numbers - B1-700-00027, B1-700-00028

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2082-2016

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