GE Voluson IC9-RS intracavitary probes — Class II medical device recall Z-0865-2024
Ongoing recall by GE HEALTHCARE AUSTRIA GMBH & CO, reported 2024-02-07. GE HealthCare has become aware of an issue with certain IC9-RS ultrasound probes (see Affected Products List)
| Recall number | Z-0865-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE HEALTHCARE AUSTRIA GMBH & CO, Pfaffing, Austria |
| Recall initiated | 2023-12-22 |
| Classified | 2024-01-30 |
| Reported by FDA | 2024-02-07 |
| Quantity | 12,004 units |
| Serial numbers | 1017062WX9, 1025309WX4, 1025310WX2, 1025376WX3, 1025378WX9, 1025393WX8, 1025396WX1, 1025409WX2, 1025410WX0, 1025429WX0, 1025451WX4, 1025452WX2, 1025453WX0, 1025457WX1, 1025458WX9, 1025462WX1, 1025464WX7, 1025465WX4, 1025467WX0, 1025468WX8, 1025469WX6, 1025471WX2, 1025474WX6, 1025481WX1, 1025490WX2 and 475 more |
| Model numbers | J48691PJ |
Product
GE Voluson IC9-RS intracavitary probes, Model Number J48691PJ, Diagnostic ultrasound imaging and fluid flow analysis
Reason for recall
GE HealthCare has become aware of an issue with certain IC9-RS ultrasound probes (see Affected Products List) that can result in a double image artifact creating a ghost image with realistic features. An unrecognized artifact may lead to misdiagnosis.
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-0865-2024. 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.