BrightView X upgraded to XCT 882454
This recall has been terminated (originally issued December 23, 2016).
- Recall Initiated
- December 23, 2016
- Terminated
- July 2, 2018
- Recall Number
- Z-1187-2017
- Firm Location
- Cleveland, OH
- Official Source
- View on FDA website ↗
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.
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.
Lot / Code Info
Two systems were converted into the BrightView XCT and are included in the codes for prouct 1.
Root Cause
Under Investigation by firm
Action Taken
All customers were notified via certified mail with return receipt. International customers were notivied via Philips employees. A field change order was initiated. Non-responders will be followed up on. Lastly, effectivenss checks will be conducted.