FDA (Devices) recall action 76183
The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
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.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Philips is recalling BrightView XCT systems because the intended use in the instructions for use did not match the 510K submission.
Philips Medical Systems is recalling 425 BrightView XCT systems because the intended use listed in the instructions for use did not match the 510K submission.