Venue Fit Models: R3 — Class II medical device recall Z-1556-2025
Ongoing recall by GE Medical Systems, LLC, reported 2025-04-23, distributed nationwide. The battery for certain ultrasound systems can potentially develop an internal failure which could result in s
| Recall number | Z-1556-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Medical Systems, LLC, Waukesha, WI, United States |
| Recall initiated | 2025-03-06 |
| Classified | 2025-04-11 |
| Reported by FDA | 2025-04-23 |
| Distributed | Nationwide (US) |
| Quantity | 12,808 systems |
| UPC / GTIN / UDI-DI | 00195278194275, 00195278361400, 00195278424938, 00195278425041, 00195278516497, 00195278516503, 00195278552402, 00195278552419, 00195278552440, 00195278552488, 00195278552495, 00195278552501, 83037829472124 |
| Serial numbers | 00060ULTA8, 00060ULTA9, 00060ULTB1, 00111ULT20, 00131ULT22, 00132ULT90, 00132ULT96, 00181ULT09, 00181ULT10, 00292ULT24, 00331ULT29, 00347ULT13, 00473ULT60, 00560ULT51, 00643ULT03, 00643ULT04, 00643ULT05, 00643ULT06, 00772ULT04, 030018US32, 030028US33, 030070US18, 030092US12, 030092US13, 05452ULT14 and 475 more |
| Model numbers | H45303VFSC, H45303VFSW, H45314VFS, H45314VFSW, H45335VFS, H45335VFSW |
Product
Venue Fit Models: R3 (Model Number H45303VFSC, H45303VFSW), R4 (Model Number H45314VFS, H45314VFSW), Venue Fit R5 system (Model Numbers H45335VFS, H45335VFSW), R3 Surgery for China, R3 PeriOP for China, R3 Expert for China, R3 Pro for China, R3 Performance for China, R3 Intervention for China diagnostic ultrasound systems
Reason for recall
The battery for certain ultrasound systems can potentially develop an internal failure which could result in smoke or fire.
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-1556-2025. 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.