BD (C.R. Bard) has received user complaints reporting that when the device was connected to WiFi/Internet, the time displayed on the Sensica device changed during a patient monitoring session which resulted in 1) incorrect time displayed on the monitoring screen, 2) incorrect hour block timestamps on the monitoring screen, 3) incorrect hour timestamps on data screens, and 4) incorrect catheter use time.
Reason for recall: BD (C.R. Bard) has received user complaints reporting that when the device was connected to WiFi/Internet, the time displayed on the Sensica device changed during a patient monitoring session which resulted in 1) incorrect time displayed on the monitoring screen, 2) incorrect hour block timestamps on the monitoring screen, 3) incorrect hour timestamps on data screens, and 4) incorrect catheter use time. Distribution: US Nationwide distribution. Quantity: 148 units Lot/code info: UDI/DI 00801741215773, Serial numbers: BMGPRMYS001 , BMGPRMYS003, BMGPRMYS004, BMGPRMYS005, BMGPRMYS006, BMGPRMYS007, BMGPRMYS020, BMGPRMYS026, BMGPRMYS028, BMGPRMYS030, BMFWRMSBT4, BMFWRMSJ45, BMFWRMSJ49, BMFZRMS104, BMGNRMS085, BMFSRMSH98, BMFSRMSJ01, BMFVRMSQ62, BMFVRMSQ66, BMFVRMSQ68, BMFYRMSJ41, BMFYRMSJ49, BMFZRMS067, BMFZRMS070, BMFZRMS080, BMFZRMS113, BMFZRMS117, BMGNRMS070, BMFURMSF02, BMFURMSF04, BMFURMSF14, BMFURMSF21, BMFVRMSQ51, BMFVRMSQ52, BMFVRMSQ54, BMFVRMSQ79, BMFVRMSQ83, BMFVRMSQ89, BMFVRMSQ91, BMFWRSJ46, BMGPRMYS011, BMGPRMYS018, BMGPRMYS022 , BMGPRMYS023, BMGPRMYS027, BMFYRMSJ35, BMFYRMSJ37, BMFYRMSJ54, BMFYRMSJ58, BMGNRMS079, BMGNRMSG69, BMGNRMSG74, BMFSRMSH94, BMFSRMSH99, BMFSRMSJ38, BMFSRMSJ44, BMFTRMS138, BMFSRMSJ13, BMFSRMSJ27, BMFSRMSJ33, BMFSRMSJ34, BMFQRMS248, BMFQRMS250, BMFRRMS646, BMFRRMS647, BMGPRMYS008, BMGPRMYS009, BMGPRMYS010, BMGPRMYS013, BMGPRMYS014, BMGPRMYS016, BMFZRMS073, BMFSRMSH78, BMFSRMSH79, BMFSRMSH80, BMFSRMSH81, BMFSRMSH82, BMFSRMSH83, BMFSRMSH93, BMFSRMSJ00, BMFSRMSJ14, BMFSRMSJ15, BMFQRMS246, BMFWRMSJ39, BMFWRMSJ41, BMFSRMSJ36, BMFSRMSJ37, BMFSRMSJ42, BMFTRMS106, BMFTRMS109, BMFTRMS114, BMFTRMS142, BMFURMSF01, BMFURMSF05, BMFSRMSH95, BMFSRMSH97, BMFTRMS120, BMFTRMS122, BMFTRMS123, BMFTRMS135, BMFTRMS136, BMFTRMS137, BMGPRMYS002, BMGPRMYS012, BMGPRMYS019 , BMGPRMYS029, BMFPRMYS009, BMFQRMS244, BMFQRMS272, BMFQRMS276, BMFQRMS286, BMFQRMS293, BMFSRMSJ43, BMFTRMS121, BMGNRMS067, BMGNRMS076, BMFVRMSQ58, BMFVRMSQ70, BMFVRMSQ73, BMFVR
00801741215773
Official record: FDA (Device enforcement) ↗
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