Home / Recalls / Medical Devices
Philips Medical Systems (Cleveland) Inc recalls BrightView X upgraded to XCT 882454
Recalled February 22, 2017 · FDA recall Z-1187-2017 · Philips Medical Systems (Cleveland)
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. · FDA Class II
Units
N/A
Sold at
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.
Description
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.
Product
BrightView X upgraded to XCT 882454
Manufacturer(s)
Philips Medical Systems (Cleveland) Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →