FDA (Devices) recall action 81058
The FDA (Devices) publishes a recall like this one as 6 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 6 pages.
The patient monitors may simultaneously restart as designed if all are connected to the same network and a network overload occurs for a prolonged time.
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.
GE Healthcare is recalling approximately 3,864 Solar 9500 Information Monitoring Systems because they may simultaneously restart if connected to the same network during a prolonged network overload.
GE Healthcare is recalling Dash 3000 patient monitors because they may restart simultaneously during prolonged network overloads.
GE Healthcare is recalling approximately 73,673 Solar 8000i and 8000M patient monitoring systems because they may simultaneously restart during prolonged network overloads.
GE Healthcare is recalling approximately 182,640 Dash 5000 Patient Monitoring Systems because they may simultaneously restart during prolonged network overloads.
GE Healthcare is recalling Dash 4000 Patient Monitoring Systems because they may simultaneously restart if connected to the same network during a prolonged network overload.
GE Healthcare is recalling Solar 8000M patient monitors because they may restart simultaneously during network overload, potentially disrupting patient monitoring.