FDA (Devices) recall action 97646
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.
Carescape Central Station (CSCS), software version V3.0.5, can cause the system to enter a continuous reboot cycle. If this occurs, a loss of central monitoring of connected patients could result. This issue occurs only when the number of central stations connected to the network is 118, 119 or 120.
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 173 Carescape Central Stations running software V3.0.5 because the system can enter a continuous reboot cycle, losing central monitoring of connected patients.
GE HealthCare is recalling 2,306 Carescape Central Stations running software V3.0.5 because the system can enter a continuous reboot cycle, losing central monitoring of connected patients.