FDA-Device2017-02-22Class II
BrightView XCT
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
425
Manufactured in
595 Miner Rd, N/A, Cleveland, OH, United States
Products
BrightView XCT
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1186-2017Don't want to check this manually?
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