Home/Recalls/FDA-Z-2247-2026
FDA DevicesClass II

GE HealthCare ApexPro v6.0 eDelivery Software, REF #5700026, Product Code SUV; u...

Published: June 3, 2026Recall ID: Z-2247-2026Category: devicesCountry: US

Reason for Recall / 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).

Product Description & Identification

GE HealthCare ApexPro v6.0 eDelivery Software, REF #5700026, Product Code SUV; used in conjunction wtih ApexPro CARESCAPE Telemetry Server (CTS) v6.0; Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

Additional Source Details

FieldValue
CityWaukesha
StateWI
Event id98938
Address 13114 N Grandview Blvd
Code infoUDI (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, SUV251128... [TRUNCATED]
Postal code53188-1615
Report date20260603
Product typeDevices
Product quantity2187 units
Reason for recallGE 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).
Voluntary mandatedVoluntary: Firm initiated
Recall initiation date20260424
Initial firm notificationLetter
Center classification date20260528

Overview

  • Recalling FirmGE Medical Systems Information Technologies Inc
  • StatusOngoing
  • Risk LevelClass II
  • DistributionWorldwide distribution.
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