FDA (Devices) recall action 69752
The FDA (Devices) publishes a recall like this one as 9 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 9 pages.
Philips Healthcare made changes to the design of the connection between multifunction electrodes and their HeartStart FR3 and HeartStart FRx AEDs. The failure to connect may result in a delay of therapy, which could result in patient death or serious injury.
The agency’s own wording, quoted from the enforcement report.
ConMed is recalling Adult Radiotransparent Electrodes because design changes to Philips AEDs may prevent connection, delaying therapy and risking patient death or serious injury.
ConMed is recalling multifunction electrodes due to a design change that may prevent connection to Philips AEDs, potentially delaying therapy.
ConMed is recalling 174,610 pediatric electrodes because design changes to Philips AEDs may prevent connection, delaying therapy and risking death or serious injury.
ConMed is recalling 174,610 Adult Radiotransparent Electrodes because design changes to Philips AED connections may cause therapy delays, risking patient death or serious injury.
ConMed is recalling 174,610 Adult Radiotransparent Electrodes because design changes to Philips AED connections may cause therapy delays, risking patient death or serious injury.
ConMed is recalling Adult Radiotransparent Electrodes because design changes to Philips AED connections may cause connection failures, potentially delaying therapy and resulting in patient death or serious injury.
ConMed is recalling Pediatric R2 Multifunction Electrodes because design changes to the connection with Philips Heartstart devices may cause connection failures, potentially delaying therapy and leading to patient death or serious injury.
ConMed is recalling 174,610 pediatric radiotransparent electrodes because design changes to Philips AED connections may cause therapy delays, risking patient death or serious injury.
ConMed is recalling Adult Radiotransparent Electrodes because a design change in Philips AEDs may prevent connection, delaying therapy and risking patient death or serious injury.