FDA (Devices) recall action 97612
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.
Failure of Environmental Stress Testing from a pinched power module wire within the housing of the Cardiac Workstation device which resulted in a short.
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 29 Cardiac Workstation 7000 units after environmental stress testing failed because a pinched power module wire inside the housing resulted in a short.
Philips is recalling 28 Cardiac Workstation 5000 units after environmental stress testing failed because a pinched power module wire inside the housing resulted in a short.