FDA (Devices) recall action 75551
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.
It was discovered the patient support tabletop may fail to move in the horizontal direction when it is commanded to do so during CT scans due to a potential mechanical linkage failure.
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 1,363 CT scanners because the patient support tabletop may fail to move horizontally during scans due to a mechanical linkage failure.
Philips is recalling 1,363 CT scanners because the patient support tabletop may fail to move horizontally during scans due to a mechanical linkage failure.