FDA-Device2017-02-22Class II
BrightView X upgraded to XCT 882454
Philips Medical Systems (Cleveland) Inc
Hazard
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.
Sold states
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 Republic, Denmark, France, Gabon, Germany, Greece, India, Indonesia, Ireland, Israel, Italy, Japan, Korea, Lebanon, Lithuania, Malaysia, Netherlands, New Zealand, Norway, Panama, Poland, Portugal, Russian Federation, Saudia Arabia, Slovakia, South AFrica, Apain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Viet Nam.
Affected count
N/A
Manufactured in
595 Miner Rd, N/A, Cleveland, OH, United States
Products
BrightView X upgraded to XCT 882454
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1187-2017Don't want to check this manually?
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