GE Healthcare Finland Oy: CARESCAPE ONE, Model no. 2087075-300 - shipped with potentially affected batteries or affected batteries installed as a spare part Monitor, Physiological, Patient (With Arrhy

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: Worldwide - US Nationwide distribution. Quantity: 5935 Lot/code info: UDI-DI 00195278288639 Serial numbers SV925270018SA SV925270014SA SV925270015SA SV925260105SA SV925270020SA SV925270013SA SV925270017SA SV925270016SA SV925060394SA SV925080329SA SV925080345SA SV925080323SA SV925080348SA SV925080153SA SV925080340SA SV925080281SA SV925080346SA SV925290119SA SV925290090SA SV925180134SA SV925160111SA SV925180131SA SV925180139SA SV925180140SA SV925180142SA SV925180143SA SV925180151SA SV925180152SA SV925160114SA SV925180141SA SV925180126SA SV925180132SA SV925180136SA SV925180135SA SV925180144SA SV925180146SA SV925180149SA SV925270007SA SV925260094SA SV925270009SA SV925270010SA SV925270008SA SV925260111SA SV925270003SA SV925270011SA SV925260085SA SV925260113SA SV925270001SA SV925270002SA SV925270006SA SV925270012SA SV925270005SA SV925270004SA SV925190002SA SV925180193SA SV925100151SA SV925100149SA SNA24400063SA SV925190009SA SV925200017SA SV925200028SA SV925190021SA SV925200022SA SV925200008SA SV925200015SA SV925200016SA SV925200021SA SV925200023SA SV925190014SA SV925200013SA SV925200012SA SV925200018SA SNA24162829SA SV925290115SA SV925220285SA SV925220291SA SV925220275SA SV925220267SA SV925220311SA SV925220240SA SV925220280SA SV925210129SA SV925220304SA SV925220255SA SV925220273SA SV925220288SA SV925210198SA SV925220281SA SV925220295SA SV925210171SA SV925220241SA SV925220290SA SV925210156SA SV925210165SA SV925210164SA SV925210163SA SV925210168SA SV925210137SA SV925210131SA SV925210141SA SV925190017SA SV925210136SA SV925210152SA SV925210162SA SV92521

UPC codes

00195278288639

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.