Generic Name: (1)(2) Positron Ct Hybrid Spect System, (3) Rotating Detector Spect System For Nuclear Medicine Diagnostics — Trade Name: (1) Millennium Vg — (2) Infinia — (3) Infinia Hawkeye 4
Recall Summary GE Healthcare is recalling three nuclear medicine imaging systems (Millennium VG, Infinia, and Infinia Hawkeye 4) used in hospitals and diagnostic centers due to potential mechanical failures that could cause the detector to descend unintentionally. The affected equipment was manufactured between 2000 and 2016, and while the devices have alarm systems to alert staff if malfunctions occur, no patient injuries have been reported to date.
- Recalling firm
- Name of Manufacturer/Distributor: GE Healthcare Japan Co., Ltd. — Address of Manufacturer/Distributor: 4-7-127 Asahigaoka, Hino City, Tokyo — License Type: Class I Medical Device...
- Product
- Lot: （1）ミレニアムVG 製造番号 ： YN0498、YN0984 数量 ： ２台 出荷時期 ： 平成１２年 ２月〜平成１５年 ２月 （2）インフィニア 製造番号 ： YN1196、YN1540、YN1544、YN1545、YN1546、YN1547、YN1548、YN1551、YN1552、YN1554、 YN1555、YN1556、YN1558、YN1559、YN1561、YN1562、YN1566、YN1567、YN1572、YN1573、 YN1575、YN1578、YN1579、YN1580、YN1581、YN1582、YN1583、YN1584、YN1585、YN1586、 YN1587、YN1588、YN1589、YN1590、YN1592、YN1601、YN1641、YN1744、YN4219、YN4227、 YN4230、YN4231、YN4233、YN4237、YN4240、YN4243、YN4244、YN4248、YN4249、YN4251、 YN4252、YN4253、YN4255、YN4256、YN4257、YN4259、YN4260、YN4261、YN4262、YN4263、 YN4264、YN4265、YN4266、YN4267、YN4280、YN4288、YN4312、YN4818、YN4819、YN4820、...
- Reason
- We have been informed by the manufacturer that if mechanical failures—such as malfunctioning radial gears, gear oil leaks, or misaligned brake pads—occur on this equipment while the correct version of the gantry software is not installed, the detector may descend slowly, potentially causing unintended operation. Therefore, based on information from the manufacturer, we will provide information to our customers, inspect the gantry software version and brake components, and perform corrective work to address any issues found.
- 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/cfaa3851-30b3-4b6c-83bd-447ac8e6df9d