FDA Device recall Z-2243-2026
GE HealthCare APEXPRO v5.0 - ARK2250 - Software Disaster Recovery USB Kit - Orderable by GE Service only, REF #2108523-01
- FDA Device
- Class II
- ongoing
- Published 2026-06-03
On 2026-06-03 the FDA classified a Class II recall of GE HealthCare APEXPRO v5.0 - ARK2250 - Software Disaster Recovery USB Kit - Orderable by GE Service only, REF #2108523-01 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-2243-2026 |
| 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 v5.0 - ARK2250 - Software Disaster Recovery USB Kit - Orderable by GE Service only, REF #2108523-01; ApexPro CARESCAPE Telemetry Server (CTS) v5.0; 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 none, Serial number or Sales Order number SS921120014SA, SS921120017SA, SS921120021SA, SS921120018SA, SS921120020S…UDI none, Serial number or Sales Order number SS921120014SA, SS921120017SA, SS921120021SA, SS921120018SA, SS921120020SA, SS920390001SA, SS921120007SA, SS921120008SA, SS921120012SA, SS921120016SA, SS920500001SA, SS920500002SA, SS921120009SA, SS921120010SA. |
|---|
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-2243-2026%22
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