← FDA ENFORCEMENT
Z-2242-2026Class II

GE Medical Systems Information Technologies Inc

Recalling firm
GE Medical Systems Information Technologies Inc
Product type
Device
Status
Ongoing
Report date
2026-06-03
Distribution
Worldwide distribution.
Firm state
WI
Product quantity
476 units
Initiated by
Voluntary: Firm initiated
Reason for recall

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).

Product description

GE HealthCare CARESCAPE TELEMETRY SERVER V5 ATO MODEL, REF #2063702-101, Product Code SS9; used in conjunction with ApexPro CARESCAPE Telemetry Server (CTS) v5.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

Code / lot 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.

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.