Generic Name: General-purpose Ultrasound Imaging System — Trade Names: (1) Venue Go General-purpose Ultrasound Imaging System — (2) Venue Fit General-purpose Ultrasound Imaging System
Recall Summary Certain Venue Go and Venue Fit ultrasound imaging systems with specific software versions may experience internal battery failures that could result in smoke or fire, particularly if the battery has been in use for two years or longer. GE Healthcare Japan is recalling affected units to update the software and replace the batteries. This recall affects specific serial-numbered devices manufactured by GE Medical Systems Israel Ltd.
- Recalling firm
- Name of Manufacturer and Distributor: GE Healthcare Japan Co., Ltd. — Address of Manufacturer and Distributor: 4-7-127 Asahigaoka, Hino City, Tokyo — Type of License: Class I Medical Device...
- Product
- Lot: （１）汎用超音波画像診断装置 Venue Go 製造番号 ： VNU000056、VNU000057、VNU000058、VNU000059、VNU000060、VNU000061、VNU000062、 VNU000063、VNU000064、VNU000065、VNU000066、VNU000067、VNU000068、VNU000069、 VNU000070、VNU000071、VNU000093、VNU000094、VNU000095、VNU000096、VNU000097、 VNU000103、VNU000104、VNU000105、VNU000121、VNU000122、VNU000123、VNU000124、 VNU000128、VNU000130、VNU000137、VNU000138、VNU000142、VNU000148、VNU000149、 VNU000150、VNU000151、VNU000152、VNU000153、VNU000154、VNU000155、VNU000156、 VNU000157、VNU000158、VNU000192、VNU000195、VNU000196、VNU000197、VNU000198、...
- Reason
- According to a report from the manufacturer, it has been determined that certain models of devices equipped with specific software versions (Venue Go R2, R3, R4, R5; Venue Fit R3, R4, R5)(*) may experience internal battery failures. This issue could lead to smoke or fire if the battery has been in use for two years or more. Therefore, based on information from the manufacturer, we are issuing a safety alert to inform customers, updating the software to a version that addresses the issue, and performing a recall to replace the batteries.
- Classification
- Class II
- Category
- medical device recall
- Country
- Japan
- Agency
- PMDA-DEVICE
- Status
- Ongoing
Official recall notice from PMDA-DEVICE
Recall details on Nibble Recalls: https://trynibble.app/recalls/11fc2f9b-ebd5-4801-9a73-5aa223bc01b6