FDA Device recall Z-1556-2025
Venue Fit Models: R3 (Model Number H45303VFSC, H45303VFSW), R4 (Model Number H45314VFS, H45314VFSW), Venue Fit R5 system (Model Numbers H45…
- FDA Device
- Class II
- ongoing
- Published 2025-04-23
On 2025-04-23 the FDA classified a Class II recall of Venue Fit Models: R3 (Model Number H45303VFSC, H45303VFSW), R4 (Model Number H45314VFS, H45314VFSW), Venue Fit R5 system (Model Numbers H45… by Ge Medical Systems, citing the battery for certain ultrasound systems can potentially develop an internal failure which could result in smoke or fire.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1556-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-03-06 |
| Published | 2025-04-23 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Ge Medical Systems |
| Distribution | US |
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
The battery for certain ultrasound systems can potentially develop an internal failure which could result in smoke or fire.
Identifiers
| code_info | UDI-DI: Venue Fit R3 system (GTIN 00195278194275 / GTIN 00195278361400); Venue Fit R4 system (GTIN 00195278516497 / GTI…UDI-DI: Venue Fit R3 system (GTIN 00195278194275 / GTIN 00195278361400); Venue Fit R4 system (GTIN 00195278516497 / GTIN 00195278516503); Venue Fit R3 Surgery for China (GTIN 00195278552488); Venue Fit R3 PeriOP for China (GTIN 00195278552501); Venue Fit R3 Expert for China (GTIN 00195278552402); Venue Fit R3 Pro for China (GTIN 00195278552419); Venue Fit R3 Performance for China (GTIN 00195278552440); Venue Fit R3 Intervention for China (GTIN 00195278552495); Venue Fit R5 system (GTIN 00195278424938 / GTIN 00195278425041); Serial IDs: VFC001530 VFD000259 RVFD000123 RVFD000429 VFD001037 RVFD000030 RVFD000035 RVFD000523 VFC000864 VFC000873 VFC000877 VFC000881 VFC000364 VFC000638 VFC000640 VFC000490 RVFC000952 RVFD000297 VFD000567LO VFD000632 VFC000297 VFC000865 VFC000871 RVFD000061 RVFD000432 VFC000665 VFC001417 RVFD000036 VFC001289 RVFD000059 VFC000435 VFC000644 VFD000633 VFC001324 VFD000797 VFC001277 VFD000665 VFD000668 VFC000819 VFC000506 VFC000507 VFC000516 VFD000578 RVFD000122 VFC |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1556-2025%22
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