GE Medical Systems Information Technologies Inc: GE HealthCare CARESCAPE TELEMETRY SERVER V5 ATO MODEL, REF #2063702-101, Product Code SS9; used in conjunction with ApexPro CARESCAPE Telemetry Server

Hazard

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).

Details from the source

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). Distribution: Worldwide distribution. Quantity: 476 units 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,

UPC codes

00840682144773

Source

Official record: FDA (Device enforcement) ↗

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