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Recall Observatory FDA recall evidence

Device product

BrightView X upgraded to XCT 882454

Z-1187-2017

December 23, 2016

Class II

Product summary

Firm
Philips Medical Systems (Cleveland) Inc
Event
Event 76183
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
device-enforcement:Z-1187-2017

Official wording

Reason: 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.

Code information: Two systems were converted into the BrightView XCT and are included in the codes for prouct 1.

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.