FDA (Devices) recall action 65031
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.
Customers at 4 facilities reported receiving duplicate alerts using the QuietCare-Networked product.
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.
Intel-GE Care Innovations is recalling 46 QuietCare-Networked devices due to duplicate alerts. The devices are used to monitor senior housing residents.
Intel-GE Care Innovations LLC is recalling QuietCare monitoring systems because customers reported receiving duplicate alerts. The recall affects 1,722 units distributed in the US and Great Britain.