GE Medical Systems Information Technologies Inc recalls GE HealthCare CARESCAPE TELEMETRY SERVER V5 ATO MODEL, REF #

Hazard / Issue

GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center (Central Station).

Issued by

FDA

Distribution: Worldwide distribution.

Lot/Code Info: UDI (01)00840682144773(10)v5.0.2R1C1, Serial Number or Sales Order Number: SS924160026SA, SS921080002SA, SS923080001SA, SS923080006SA, SS922460008SA, SS921320004SA, SS921320010SA, SS921320012SA, SS922120001SA, SS921210005SA, SS921060024SA, SS921060026SA, SS924290077SA, SS923290011SA, SS923290012SA, SS923290013SA, SS923290014SA, SS921520004SA, SS922080001SA, SS922080002SA, SS922120002SA, SS922120003SA, SS924200022SA, SS924450085SA, SS924220065SA, SS921210002SA, SS921210003SA, SS924220066SA, SS924050001SA, SS922170005SA, SS924160027SA, SS924160028SA, SS924160029SA, SS924160031SA, SS924160032SA, SS924160033SA, SS921300003SA, SS921420015SA, SS921420016SA, SS921520002SA, SS920520004SA, SS922250001SA, SS923510002SA, SS923510003SA, SS924160023SA, SS924170017SA, SS924200031SA, SS924200032SA, SS924090011SA, SS924090016SA, SS924090018SA, SS924090020SA, SS924090021SA, SS924090024SA, SS924140003SA, SS924140006SA, SS924140011SA, SS924140012SA, SS924140014SA, SS924170006SA, SS924170007SA, SS924170008SA, SS924170009SA, SS924170010SA, SS924170011SA, SS924170012SA, SS924170013SA, SS924170014SA, SS924170015SA, SS924170016SA, SS921110009SA, SS921420013SA, SS922170004SA, SS922340005SA, SS922290002SA, SS923220003SA, SS923290008SA, SS924020004SA, SS921040002SA, SS921050002SA, SS921060023SA, SS921060025SA, SS921060020SA, SS921060022SA, SS921060016SA, SS921060017SA, SS921060018SA, SS921060021SA, SS921110004SA, SS921110001SA, SS921240007SA, SS920490011SA, SS924430083SA, SS924050023SA, SS924060001SA, SS922080004SA, SS922080005SA, SS922080006SA, SS923240002SA, SS923520001SA, SS922120004SA, SS922390002SA, SS923400001SA, SS922340008SA, SS922340009SA, SS922340010SA, SS922020001SA, SS923230004SA, SS923230005SA, SS923230006SA, SS923470001SA, SS923470002SA, SS923470003SA, SS923470006SA, SS923470007SA, SS923480001SA, SS924060011SA, SS922240002SA, SS924060012SA, SS924070006SA, SS924070010SA, SS921110005SA, SS921180006SA, SS921420001SA, SS921470002SA, SS921470004SA, SS922250003SA, SS922340004SA, SS922460004SA, SS922460007SA, SS924060008SA, SS924060009SA, SS924060010SA, SS922130001SA, SS921300001SA, SS922410002SA, SS920500009SA, SS920500008SA, SS921240009SA, SS923430002SA, SS922010003SA, SS923370001SA, SS924050013SA, SS924050025SA, SS924050009SA, SS924050010SA, SS924050017SA, SS924290078SA, SS920430005SA, SS920430006SA, SS920460004SA, SS921140001SA, SS924040005SA, SS920450002SA, SS920450003SA, SS923230017SA, SS924070007SA, SS924070005SA, SS924090013SA, SS924090014SA, SS923250002SA, SS923250003SA, SS920520001SA, SS921180010SA, SS922340011SA, SS920490001SA, SS923030004SA, SS923240001SA, SS924140001SA, SS923110002SA, SS924040006SA, SS922310001SA, SS921080001SA, SS924050007SA, SS921180008SA, SS923520002SA, SS922340006SA, SS924050016SA, SS924050012SA, SS924150001SA, SS924150002SA, SS921320001SA, SS921320002SA, SS921320003SA, SS921320006SA, SS921320007SA, SS921320008SA, SS921320009SA, SS921320011SA, SS921300005SA, SS921240001SA, SS920450001SA, SS921300006SA, SS923450001SA, SS921520003SA, SS924130001SA, SS924130003SA, SS922410003SA, SS922460003SA, SS921520008SA, SS924130004SA, SS920430001SA, SS920510003SA, SS920510007SA, SS920510010SA, SS923070001SA, SS921300002SA, SS924070009SA, SS922040008SA, SS920510009SA, SS924050003SA, SS922090001SA, SS923290007SA, SS923300001SA, SS923300002SA, SS924050006SA, SS924050011SA, SS924050008SA, SS922080003SA, SS923030003SA, SS921130001SA, SS921150001SA, SS921150002SA, SS921460009SA, SS921320005SA, SS922180001SA, SS920490002SA, SS921460007SA, SS924050005SA, SS925270092SA, SS925270093SA, SS925270095SA, SS925270094SA, SS924160022SA, SS924050015SA, SS925330096SA, SS920430002SA, SS920430004SA, SS924070015SA, SS925260090SA, SS925260091SA, SS921460005SA, SS922250002SA, SS923030002SA, SS923030006SA, SS924050014SA, SS924430084SA, SS921470005SA, SS921210001SA, SS921210007SA, SS921210008SA, SS921210009SA, SS921210010SA, SS924050004SA, SS923230026SA, SS921420017SA, SS921150003SA, SS921050001SA, SS924070003SA, SS924070004SA, SS922120005SA, SS922250004SA, SS924200024SA, SS924200025SA, SS924200026SA, SS924200027SA, SS924200028SA, SS924200029SA, SS924200030SA, SS921110003SA, SS923110003SA, SS922390001SA, SS922290001SA, SS924140004SA, SS923200001SA, SS921150005SA, SS924090017SA, SS923290006SA, SS921240004SA, SS921240005SA, SS921240006SA, SS921240010SA, SS921460003SA, SS921420018SA, SS921420019SA, SS924170004SA, SS924170005SA, SS924170003SA, SS924090015SA, SS924140016SA, SS924090027SA, SS924090026SA, SS924090023SA, SS924090006SA, SS922040001SA, SS924090012SA, SS921110006SA, SS924170001SA, SS924170002SA, SS924090025SA, SS924090019SA, SS923070002SA, SS923070003SA, SS922040006SA, SS923400003SA, SS921300007SA, SS922380001SA, SS921460001SA, SS921460004SA, SS920430003SA, SS921250001SA, SS923220001SA, SS922050001SA, SS922050002SA, SS922050003SA, SS922050004SA, SS924200023SA, SS924010001SA, SS924070011SA, SS920500007SA, SS920500010SA, SS922010001SA, SS923320001SA, SS923230011SA, SS923230012SA, SS923230013SA, SS923230015SA, SS923230016SA, SS923230014SA, SS923230007SA, SS923230008SA, SS923230009SA, SS923230010SA, SS922290003SA, SS921460006SA, SS922300001SA, SS923230021SA, SS923230023SA, SS923230022SA, SS923230020SA, SS923230019SA, SS923230018SA, SS924220059SA, SS924220060SA, SS920490010SA, SS923080003SA, SS923080002SA, SS922460006SA, SS922460005SA, SS924040001SA, SS921040001SA, SS922210001SA, SS924150006SA, SS924470086SA, SS924070012SA, SS924070014SA, SS924150004SA, SS924070013SA, SS921520001SA, SS924160015SA, SS924160016SA, SS924160001SA, SS924160002SA, SS924160003SA, SS924160004SA, SS924160005SA, SS924160006SA, SS924160007SA, SS924160008SA, SS924160009SA, SS924160010SA, SS924160011SA, SS924160012SA, SS924160013SA, SS924160014SA, SS921460010SA, SS924160024SA, SS923290002SA, SS923290003SA, SS922220001SA, SS922220002SA, SS922220003SA, SS921130003SA, SS921130004SA, SS925140088SA, SS924130002SA, SS923290004SA, SS923290005SA, SS922110001SA, SS922110002SA, SS921520007SA, SS921520009SA, SS921520005SA, SS924420082SA, SS924420081SA, SS922010002SA, SS924090022SA, SS925120087SA, SS922040002SA, SS922040004SA, SS922040005SA, SS921180009SA, SS922040003SA, SS922040007SA, SS920490006SA, SS920490009SA, SS924040011SA, SS922460002SA, SS922050005SA, SS921490002SA, SS923080005SA, SS924070001SA, SS924040002SA, SS921470003SA, SS920490004SA, SS920510005SA, SS921210006SA, SS920520003SA, SS920510008SA, SS920490005SA, SS921240008SA, SS924040009SA, SS921150004SA, SS922300002SA, SS921420011SA, SS920490007SA, SS920490008SA, SS921420002SA, SS920490003SA, SS920510012SA, SS920510011SA, SS923250001SA, SS924040007SA, SS922390003SA, SS922420001SA, SS921130002SA, SS921350001SA, SS923110004SA, SS924050018SA, SS924050019SA, SS924050020SA, SS924050021SA, SS924050022SA, SS924050024SA, SS923210002SA, SS923210003SA, SS924050002SA, SS921300004SA, SS922340007SA, SS923400002SA, SS923420001SA, SS924020002SA, SS920510004SA, SS924060002SA, SS921520006SA, SS923080004SA, SS922240001SA, SS923030005SA, SS921460011SA, SS920510002SA, SS924020001SA, SS924020003SA, SS923030001SA, SS921210004SA, SS924150003SA, SS921060027SA, SS921030011SA, SS923170001SA, SS922170001SA, SS922170002SA, SS922170003SA, SS923230024SA, SS920510001SA, SS922310002SA, SS923290001SA, SS922300003SA.