FDA (Devices) recall action 97786
The FDA (Devices) publishes a recall like this one as 5 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 5 pages.
Potential loss of monitoring on affected monitors when powered by certain batteries. Affected batteries can lose capability to hold charge and provide back up power. If this situation occurs, it will cause loss of patient monitoring and potentially delay recognizing patient status changes requiring treatment.
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 5,990 Portrait VSM patient monitors because certain batteries can lose the ability to hold charge, causing a loss of patient monitoring.
GE Healthcare is recalling 3,271 Carescape B450 patient monitors because certain batteries can lose the ability to hold charge, causing a loss of patient monitoring.
GE Healthcare is recalling 2,857 FLEX-3S2P lithium-ion batteries used with patient monitors because they can lose the capability to hold charge and provide backup power.
GE Healthcare is recalling 7,408 B105P, B125P, B105M, B125M and B155M patient monitors because certain batteries can lose the ability to hold charge, causing a loss of monitoring.
GE Healthcare is recalling 5,935 CARESCAPE ONE patient monitors because certain batteries can lose the ability to hold charge, causing a loss of patient monitoring.