FDA (Devices) recall action 80577
The FDA (Devices) publishes a recall like this one as 28 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 28 pages.
The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury 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 is recalling DigitalDiagnost Classic 1.x Upgrades because the footplate hook may fail to hold the plate securely, posing a risk of injury to patients or operators.
Philips is recalling DigitalDiagnost Classic units because a defective hook allows the footplate to fall or swing, posing an injury risk to patients and operators.
Philips is recalling DigitalDiagnost 4 Flex and Value units because a defective hook allows the footplate to fall or swing, posing an injury risk to patients and operators.