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

Recall date

March 17, 2016

Source

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

Recall number

Z-2082-2016

FDA classification

Class II

Brand / firm

Medtronic Navigation, Inc.-Littleton

Sold / distributed

Nationwide Distribution

Why it was recalled

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

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