Generic Name: General-purpose Medical Imaging Workstation — Trade Name: Forz Workstation (software For The Forz Workstation)
- Recalling firm
- Name of Manufacturer and Distributor: Excel Creates Co., Ltd. — Address of Manufacturer and Distributor: Sakaisuji Best Building, 1-16-13 Minami-Senba, Chuo-ku, Osaka City, Osaka Prefecture — Type...
- Product
- Lot: 製造番号： FZ180-P18934-001、FZ212-P17728-001、FZ264-P19140-001、FZ304-P211071-001、 FZ0812-P231358-001、FZ849-P17164-001、FZ862-P17248-001、FZ939-P17604-001、 FZ1042-P18464-001、FZ1099-P18914-001、FZ1101-P18933-001、FZ1122-P19360-001、 FZ1156-P19434-001、FZ1216-P19986-001、FZ1331-P210215-001、FZ1333-P210396-001、 FZ1352-P210481-001、FZ1456-P220630-001、FZ1457-P220631-001、FZ1562-P230915-001、 FZ1563-P230916-001、FZ1564-P230917-001 数量：27台 出荷時期：平成29年6月〜令和7年3月. Use: 本製品は、画像診断装置等で収集された画像や情報に対し、各種処理を行い、処理後の画像や情報を表示し、診 療のために提供します。. Health hazards: 本事象が発生した場合、メディアから取り込みした医用画像の一覧に誤った患者情報が表示されます。...
- Reason
- This product is capable of importing medical images from media such as CDs that were generated by PACS systems or other medical institutions. It has been confirmed that, under certain conditions, patient information may not be displayed correctly when importing medical images from such media using this feature. As a result of our investigation, we determined that although an error message appeared when importing medical images from media, the system was designed to allow registration regardless. Therefore, we have decided to replace the software with a revised version to prevent the...
- 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/3bd15605-8219-4160-b447-a29dcaa18afa