Generic Name: General-purpose Ultrasound Imaging System — Trade Name: Logiq P9 General-purpose Ultrasound Imaging System
- 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: 製造番号 ： LPX440990、LPX440999、LPX441001、LPX441018、LPX441043、LPX441367、LPX441368、LPX441369、 LPX441370、LPX441371、LPX441373、LPX441374、LPX441375、LPX441376、LPX441377、LPX441382、 LPX441384、LPX441399、LPX441420、LPX441421、LPX441422、LPX441423、LPX441424、LPX441425、 LPX441426、LPX441427、LPX441428、LPX441430、LPX441447、LPX441453、LPX441455 数量 ： ３１台 出荷時期 ： 令和６年６月〜令和７年４月. Use: 超音波を用いて体内の形状、性状又は動態を可視化し、画像情報を診断のために提供する装置である。また、超 音波を用いて肝臓、脾臓、膵臓、乳腺、甲状腺又は前立腺の硬さに関する情報を提供するオプション機能を有す る。. Health hazards: 超音波減衰係数は臨床現場において脂肪肝に関する情報として利用される場合がありますが、この問題の結果、 全体的な患者ケアに影響を及ぼす不適切な臨床判断につながる可能性があります。しかしながら、診断を確定す...
- Reason
- According to a report from the manufacturer, it has come to our attention that in certain units of this device running software version R4.5.7, the attenuation coefficient measured by the ultrasonic attenuation parameter (UGAP) may be inaccurate. Therefore, based on information from the manufacturer, we are issuing this notice to inform our customers and will carry out a software update to resolve the issue.
- 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/ba3e7841-3601-4d07-9056-d22aaa067da0