BrightView X upgraded to XCT 882454
FDA Recall #Z-1187-2017 — Class II — December 23, 2016
Product Description
BrightView X upgraded to XCT 882454
Reason for Recall
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.
Recalling Firm
Philips Medical Systems (Cleveland) Inc — Cleveland, OH
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
N/A
Distribution
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.
Code Information
Two systems were converted into the BrightView XCT and are included in the codes for prouct 1.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated