Generic Name: General-purpose Medical Imaging Workstation — Trade Name: Aw Server
Recall Summary GE Healthcare's AW Server medical imaging workstations are being recalled due to a security vulnerability that could allow unauthorized access to patient data if the device is not protected by a hospital's VPN or equivalent network security and does not have a strong password set. The recall affects specific serial numbers of devices manufactured by GE Healthcare Japan. The manufacturer will implement stronger passwords for maintenance accounts to address the issue.
- 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 ： AW00024、AW00027、AW00040、AW00044、AW00045、AW00067、AW00073、AW00084、 AW00107、AW00130、AW00139、AW00167、AW00172、AW00181、AW00188、AW00209、 AW00225、AW00282、AW00285、AW00302、AW00321、AW00330、EW0004、EW0007、 EW0011、EW0012、EW0013、EW0014、EW0016、EW0017、EW0018、EW0019、EW0020、 EW0023、EW0024、EW0025、EW0026、EW0027、EW0028、EW0029、EW0030、EW0031、 EW0032、EW0033、EW0034、EW0035、EW0036、EW0037、EW0038、EW0039、EW0040、 EW0041、EW0042、EW0043、EW0044、EW0045、EW0046、EW0047、EW0048、EW0049、 EW0050、EW0051、EW0052、EW0054、EW0055、EW0056、EW0057、EW0058、EW0059、 EW0060、EW0062、EW0103、EW0112、EW0113、EW0114、EW0115、EW0116、EW0120、...
- Reason
- According to a report from the manufacturer, a security vulnerability has been identified in this device under specific conditions. This issue means that if the device is not connected via the hospital’s VPN (Virtual Private Network) or an equivalent network security solution, and if a strong, secure password has not been set, the confidentiality, integrity, and availability of patient data could be compromised by malicious third parties. Therefore, based on information from the manufacturer, we are issuing this notice to alert our customers and will set stronger passwords for maintenance...
- 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/87cb5dad-e6db-4786-a98b-0e2e580e8be9