FDA Device recall Z-2247-2026
GE HealthCare ApexPro v6.0 eDelivery Software, REF #5700026, Product Code SUV
- FDA Device
- Class II
- ongoing
- Published 2026-06-03
On 2026-06-03 the FDA classified a Class II recall of GE HealthCare ApexPro v6.0 eDelivery Software, REF #5700026, Product Code SUV by Ge Medical Systems Information Technologies, citing 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 resul….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2247-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-04-24 |
| Published | 2026-06-03 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Ge Medical Systems Information Technologies |
| Distribution | n/a |
Product
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)
Reason
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).
Identifiers
| code_info | UDI (01)00195278512390(10)APv6.0.0.5, Serial Number or Sales Order Number: SUV25423440TA, SUV25423443TA, SUV25423444TA…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, SUV251128 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2247-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.