FDA (Devices) recall action 86531
The FDA (Devices) publishes a recall like this one as 7 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 7 pages.
Flow sensors could have damaged tubes in the form of small punctures or cuts.
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 388 Flow Sensor Service Parts because the tubes may have small punctures or cuts.
GE Healthcare is recalling 88 Avance CS2 Anesthesia Systems because flow sensors may have damaged tubes with small punctures or cuts.
GE Healthcare is recalling 4,794 Flow Sensor Service Parts because the tubes may have small punctures or cuts.
GE Healthcare is recalling 2 Flow Sensor Service Parts because the tubes may have small punctures or cuts.
GE Healthcare is recalling 37 9100c NXT systems because flow sensors may have damaged tubes with small punctures or cuts.
GE Healthcare is recalling 101 Aisys CS2 Anesthesia Systems because flow sensors may have damaged tubes, posing a risk to patients.
GE Healthcare is recalling two Aestiva/5 MRI Anesthesia Systems because flow sensors may have damaged tubes with small punctures or cuts.