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Medtronic Navigation, Inc.-Littleton recalls Medtronic Navigation O-arm 02 surgical x-ray imaging system
Recalled July 13, 2016 · FDA recall Z-2083-2016 · 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). · FDA Class II
Units
US - 63
Sold at
Nationwide Distribution
Description
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).
Product
Medtronic Navigation O-arm 02 surgical x-ray imaging system
Manufacturer(s)
Medtronic Navigation, Inc.-Littleton
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →