GE Medical Systems Information Technologies Inc: GE HealthCare ApexPro v6.0 eDelivery Software, REF #5700026, Product Code SUV; used in conjunction wtih ApexPro CARESCAPE Telemetry Server (CTS) v6.0;

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: 2187 units Lot/code info: UDI (01)00195278512390(10)APv6.0.0.5, Serial Number or Sales Order Number: SUV25423440TA, SUV25423443TA, SUV25423444TA, SUV25423445TA, SUV25423446TA, SUV25423447TA, SUV25493641TA, SUV26093921TA, SUV26093922TA, SUV26093923TA, SUV26093924TA, SUV26093925TA, SUV26093926TA, SUV26093927TA, SUV26093928TA, SUV26093929TA, SUV26093930TA, SUV26093931TA, SUV26093932TA, SUV26033814TA, SUV26033815TA, SUV26033816TA, SUV26033817TA, SUV26033818TA, SUV26033819TA, SUV26033820TA, SUV25112833TA, SUV25112834TA, SUV25202954TA, SUV24251609SA, SUV24251610SA, SUV24251611SA, SUV24251612SA, SUV24251613SA, SUV24251614SA, SUV24251615SA, SUV24251616SA, SUV24141336SA, SUV23260213SA, SUV23260214SA, SUV23260215SA, SUV23260216SA, SUV23260217SA, SUV24241569SA, SUV24241570SA, SUV24241574SA, SUV25122865TA, SUV25122866TA, SUV25122867TA, SUV25122868TA, SUV26083897TA, SUV23510727SA, SUV23510728SA, SUV23510729SA, SUV23510730SA, SUV23510731SA, SUV23510732SA, SUV23510733SA, SUV23510734SA, SUV23510735SA, SUV23510736SA, SUV25112811TA, SUV25112812TA, SUV25102746TA, SUV25102747TA, SUV25102748TA, SUV23400387SA, SUV23400388SA, SUV23400389SA, SUV23400390SA, SUV24091167SA, SUV24091168SA, SUV24091169SA, SUV24091170SA, SUV24091171SA, SUV24091172SA, SUV24091173SA, SUV24091174SA, SUV23460644SA, SUV23460645SA, SUV23460646SA, SUV23460647SA, SUV25283133TA, SUV23440442SA, SUV23440443SA, SUV23440444SA, SUV23440445SA, SUV23440446SA, SUV23440447SA, SUV23280235SA, SUV23410401SA, SUV25132875TA, SUV25243037TA, SUV25243038TA, SUV25243039TA,

UPC codes

00195278512390

Source

Official record: FDA (Device enforcement) ↗

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