Medtronic Navigation, Inc.-Littleton recalls Medtronic Navigation O-arm 02 surgical x-ray imaging system

Recall date

March 17, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2083-2016

FDA classification

Class II

Brand / firm

Medtronic Navigation, Inc.-Littleton

Sold / distributed

Nationwide Distribution

Why it was recalled

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).

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Medtronic Navigation O-arm 02 surgical x-ray imaging system