FDA (Devices) recall action 82684
The FDA (Devices) publishes a recall like this one as 8 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 8 pages.
System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute.
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 SureSigns VS3 monitors because a software defect prevents the device from measuring, displaying, or alarming for pulse rates above 240 beats per minute.
Philips is recalling SureSigns VS3 monitors because a software defect prevents the device from measuring, displaying, or alarming for pulse rates above 240 beats per minute.
Philips is recalling SureSigns VS3 patient monitors because a software defect prevents the device from measuring or alarming for pulse rates above 240 beats per minute.
Philips is recalling SureSigns VS4 monitors because software prevents the device from measuring or alarming for pulse rates above 240 beats per minute.
Philips is recalling 518 SureSigns VS3 monitors because a software defect prevents the device from measuring or alarming for pulse rates above 240 beats per minute.
Philips is recalling 366 SureSigns VS4 monitors because software prevents the device from measuring or alarming for pulse rates above 240 beats per minute.
Philips is recalling SureSigns VS3 NBP monitors because software prevents the display and alarm for pulse rates above 240 beats per minute.
Philips is recalling 3,177 SureSigns VS3 monitors because a software defect prevents the device from measuring, displaying, or alarming for pulse rates above 240 beats per minute.