GE HealthCare APEXPRO v5 — Class II medical device recall Z-2243-2026
Ongoing recall by GE Medical Systems Information Technologies Inc, reported 2026-06-03. GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involv
| Recall number | Z-2243-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Medical Systems Information Technologies Inc, Waukesha, WI, United States |
| Recall initiated | 2026-04-24 |
| Classified | 2026-05-28 |
| Reported by FDA | 2026-06-03 |
| Quantity | 14 units |
| Model numbers | 2108523-01 |
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 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).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2243-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.