Generic Name: Superconducting Magnet-type Whole-body Mri System — Trade Names: (1) Gyroscan Intera 1.5t — (2) Intera Achieva 1.5t — (3) Achieva 3.0t — (4) Achieva 3.0t Tx — (5) Whole-body Mri System Intera/achieva 1.5t — (6) Whole-body Mri System Achieva 3.0t
- Recalling firm
- Name of Manufacturer and Distributor: Philips Japan, Ltd. — Address of Manufacturer and Distributor: Azabudai Hills Mori JP Tower, 1-3-1 Azabudai, Minato-ku, Tokyo — License Type: Class I Medical...
- Product
- Lot: （1）ジャイロスキャン インテラ 1.5T 製造番号：8684 対象台数：1台 出荷時期：平成14年11月 （2）インテラ アチーバ 1.5T 製造番号：20010, 20241, 20323, 20326, 20335, 21120, 21578, 21698, 21938, 22075, 32146, 32177, 32356, 32402, 32413, 32480 対象台数：16台 出荷時期：平成17年11月〜平成22年7月(*) （3）アチーバ 3.0T 製造番号：17500, 34038, 34135, 34160 対象台数：4台 出荷時期：平成20年3月〜平成22年4月(*) （4）アチーバ 3.0T TX 製造番号：38021, 38104, 38137, 38169, 38186, 38187, 38223, 38273, 38280 対象台数：9台 出荷時期：平成22年4月〜平成24年9月 （5）全身用MR装置 Intera／Achieva 1.5T 製造番号：22148, 32370, 32516, 32548, 32553, 32567, 32572, 32578, 32590, 32595, 32597, 32618, 32625, 32681, 32713, 32734, 32749, 32751, 32775, 32811,...
- Reason
- Based on an investigation conducted by the overseas manufacturer using information gathered from the market, it has been confirmed that if a specific component installed inside the gradient coil of the affected MR system fails, there is a risk of smoke or fire. If this occurs, the scan may repeatedly abort, abnormal noises may be heard from the examination room or machine room, or smoke or fire may emanate from the system. Additionally, it has been confirmed that localized heating may occur during scans with specific SENSE XL torso coils used in this MR system, potentially causing 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/e4eb6106-343b-462b-aaca-922b70736a4a