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FDADecember 23, 2016device

BrightView X upgraded to XCT 882454

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

philips medical systems clevelandphilipsphilips medical

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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BrightView X upgraded to XCT 882454 — Recall Details · AllClear