Device evidence

device-recall:cfres:213123

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

Official recall number

Z-1556-2025

Evidence summary

Product code: IYN
Recall status: Open, Classified
Event initiated: March 06, 2025
Root cause: Under Investigation by firm
Source snapshot: 5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product: Z-1556-2025