medical Class II Updated 2017-02-22

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.
View official government recall

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