Generic Name: Ultrasound Workstation — Trade Name: Viewpoint 6 Ultrasound Workstation
Consumer Summary GE Healthcare is recalling ViewPoint 6 Ultrasound Workstations (specific serial numbers and software versions 6.15.3 and 6.15.4) because patient medical history information—such as allergies, medications, and past medical conditions—fails to display when opening patient exams. While this could potentially lead to medication errors or unnecessary procedures, the manufacturer states that no serious patient harm has occurred, as doctors typically review additional medical records before making treatment decisions.
- 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: 製造番号 ： JPH0469K91、JPH0469P4F、JPH052FVJM、JPH447SW05、JPH5020KTG、JPH916ZX2Z、JPH0469P4B(*)、 JPH053G6HV(*)、JPH239T66R(*)、JPN10500G9(*) 数量 ： １０台(*) 出荷時期 ： 令和元年９月〜令和７年５月. Use: 画像診断装置等から提供された人体の画像情報をコンピュータ処理し、処理後の画像情報を診療のために提供す ること。(本装置は自動診断機能を有さない). Health hazards: この問題により、患者の既往歴の情報が見逃された場合、誤った投薬や不要な処置に繋がる可能性があります。 しかしながら、治療方針を確定する場合には、電子カルテや過去の検査データも含めて総合的に判断さることか ら、本事象により患者へ重篤な健康被害が発生することは無いと考えております。 なお、これまでに本事象による健康被害の発生は報告されておりません。
- Reason
- According to a report from the manufacturer, it has been discovered that on devices running specific software versions (versions 6.15.3 and 6.15.4), when a new examination is created or opened, the patient’s medical history information (e.g., allergies, current medications, past medical history, history of surgery, obstetric and gynecological history, infectious diseases, etc.) displayed on the “Patient History” tab does not appear. Therefore, based on information from the manufacturer, we will issue a safety advisory to our customers and perform maintenance to update the software to a...
- 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/a174d1aa-cd6d-44e3-bee6-d5da7f6c2b24