GE Medical Systems, LLC: Venue Fit Models: R3 (Model Number H45303VFSC, H45303VFSW), R4 (Model Number H45314VFS, H45314VFSW), Venue Fit R5 system (Model Numbers H45335VFS, H45335VFSW), R3 Surgery for

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 systems Lot/code info: 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 VFC001254 RVFC000164 VFD000295 VFC001205 VFC000470 VFD000522 VFC000111 VFD000334 VFD001053 VFC000614 RVFD000071 RVFD000072 VFD000073 VFC000942 RVFD000947 VFD000985 VFD000534 VFC000527 VFC000251 VFC001225 VFD000250 VFC001535 VFC001535 VFD000883 VFC001323 VFD000781 VFD001081 RVFD000019 VFC001370 VFC001371 RVFD000067 RVFC001427 VFD000184 VFC000349 VFC001538 VFC001542 VFC001519 VFC000981 VFC000985 VFC000511 VFC000515 VFC001647 VFC001143 VFD000150 VFD000614 VFD000646 VFD000647 VFD000622 VFC000351 VFC0003

UPC codes

00195278194275, 00195278361400, 00195278516497, 00195278516503, 00195278552488, 00195278552501, 00195278552402, 00195278552419, 00195278552440, 00195278552495, 00195278424938, 00195278425041, 83214160411, 83214159627, 83214160953, 83214160628, 83214159760, 83214159584, 83214160624, 83214159723

Source

Official record: FDA (Device enforcement) ↗

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