BrightView X upgraded to XCT 882454
Reported: February 22, 2017 Initiated: December 23, 2016 #Z-1187-2017
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.
Details
- Recalling Firm
- Philips Medical Systems (Cleveland) Inc
- Units Affected
- 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.
- Location
- Cleveland, OH
Frequently Asked Questions
What product was recalled? ▼
BrightView X upgraded to XCT 882454. Recalled by Philips Medical Systems (Cleveland) Inc. Units affected: N/A.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 22, 2017. Severity: Moderate. Recall number: Z-1187-2017.
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