FDA (Devices) recall action 69090
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 hook does not securely hold the footplate in vertical position. Therefore the footplate can fall or swing down and may hurt the operator or patient.
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 Medical Systems is recalling patient support materials for the EasyDiagnost device because the footplate hook may fail, causing the footplate to fall or swing and potentially injure patients or operators.
Philips Medical Systems is recalling BuckyDiagnost patient support materials because the footplate hook may fail, causing the plate to fall or swing and injure patients or operators.