Philips Medical Systems (Cleveland) Inc recalls BrightView X upgraded to XCT 882454

Recall date

December 23, 2016

Source

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

Recall number

Z-1187-2017

FDA classification

Class II

Brand / firm

Philips Medical Systems (Cleveland) Inc

Sold / distributed

Products were distributed in the following states: AZ, CA, CO, DC, DE, FL, GA, IL, LA, MA, MD, MN, MO, MS, MT, NC, NJ, NY, OH, OK, OR, PA, PR, TX, VT, WA, & WI. Product was distributed internationally to the following countries: Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czech Repub…

Why it was recalled

The intended use listed in the English and localized language IFUs for BrightView XCT systems did not match the intended use documented in the 510K submission.

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 X upgraded to XCT 882454