GE Medical Systems, LLC: Venue Go Models: R2 (Model Number H45181VG), R3 (Model Number H45193VG), R4 (Model Number H45114VG), R5 (Model Numbers H45135VG, H45135VGW), R3 Surgery for China (Model Number

Hazard

The battery for certain ultrasound systems can potentially develop an internal failure which could result in smoke or fire.

Details from the source

Reason for recall: The battery for certain ultrasound systems can potentially develop an internal failure which could result in smoke or fire. Distribution: Worldwide - US Nationwide distribution. Quantity: 12,808 total devices Lot/code info: UDI-DI: Venue Go R2 system (GTIN 00840682138840); Venue Go R3 system (GTIN 00840682190503 / GTIN 00195278358011); Venue Go R4 system (GTIN 00195278516510 / GTIN 00195278516527); Venue Go R3 Surgery for China (GTIN 00195278547866) Venue Go R3 PeriOP for China (GTIN 00195278548344) Venue Go R3 Expert for China (GTIN 00195278547262) Venue Go R3 Pro for China (GTIN 00195278547828) Venue Go R3 Performance for China (GTIN 00195278547842) Venue Go R3 Intervention for China (GTIN 00195278548061) Venue Go R5 system (GTIN 00195278450319 / GTIN 00195278451774); System ID: VENGO000382 VGB002128 VGB003021 VGD000325 VGD002313 VGD000452 VGD000488 VGD002390 VGC006411 VGB002040 VGD000354 VGC000685 VGD001444 VGC006698 VGC007776 RVGC000034 RVGC000035 VGD002256 VGD002533 VGD002535 VGD002536 VGB001162 VGC007292 VGC007119 VGC006083 VGC006841 VGB001011 VGC000147 VGD001510 RVGC000559 RVGC000562 VGD000044 VGD001371 VGD001372 VGD001375 VGD001374 VGD001373 VGD001625 VGD001638 VGC000526 RVGD002184 VGD002513 VGB002239 VGD001705 VGD002307 VGC000746 VGC004373 VGC004378 VGC006707 RVGC007218 RVGC000591 VGD001899 RVGC004147 VGC004351 VGC007098 VGC007102 VGC007105 RVGC000024 RVGC004165 RVGD001551 RVGB000480 RVGB002675 VGC007113 VGD000091 RVGD001076 RVGB000467 VENGO000545 VGC007350 VGD001731 VGB002526 VGC000227 VGD001964 VGD002225 RVGC000303 RVGB000757 RVGB000797 RVGC000302 RVGC000554 VGC000799 RVGC006372 RVGC006771 VGC007879 VGC007880 VGD000524 RVGB000791 VGD001873 VGD002221 VGD002227 VGD002467 VGD000730 VGD00

UPC codes

00840682138840, 00840682190503, 00195278358011, 00195278516510, 00195278516527, 00195278547866, 00195278548344, 00195278547262, 00195278547828, 00195278547842, 00195278548061, 00195278450319, 00195278451774

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.