Philips Medical Systems (Cleveland) Inc recalls BrightView model number: 882478 BrightView X model number: 882480 BrightView XCT model number: 882482 and 882454 Medica…

Recall date

November 12, 2014

Source

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

Recall number

Z-1011-2015

FDA classification

Class II

Brand / firm

Philips Medical Systems (Cleveland) Inc

Sold / distributed

Worldwide Distribution - USA (nationwide) and Internationally to Canada, Algeria, Argentina, Australia, Austria, Bahrain, Belgium, Brazil, China, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, France, Gabon, Germany, Greece, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Leban…

Why it was recalled

Unintended detector and gantry movement due to software issues.

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

What was recalled

BrightView model number: 882478 BrightView X model number: 882480 BrightView XCT model number: 882482 and 882454 Medical Device for imaging