FDA-Device2016-07-13Class II
Medtronic Navigation O-arm 02 surgical x-ray imaging system
Medtronic Navigation, Inc.-Littleton
Hazard
Review of on-system electronic product labeling and Instr uctions for Use in response to an internal management concern uncovered gaps in compliance with the requirements for information to be provided to users in 21CFR part 1 020.30(h).
Sold states
Nationwide Distribution
Affected count
US - 63
Manufactured in
300 Foster Street, N/A, Littleton, MA, United States
Products
Medtronic Navigation O-arm 02 surgical x-ray imaging system
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2083-2016Don't want to check this manually?
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