Philips Medical Systems (Cleveland) Inc recalls BrightView X upgraded to XCT 882454
Recalled Product
BrightView X upgraded to XCT 882454
Hazard / Issue
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.
Issued by
FDA
Affected States: AZ, CA, CO, DC, DE, FL, GA, IL, LA, MA, MD, MN, MO, MS, MT, NC, NJ, NY, OH, OK, OR, PA, TX, VT, WA, WI
Lot/Code Info: Two systems were converted into the BrightView XCT and are included in the codes for prouct 1.
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