Generic Name: (1)(2) Multiphase Electric Contrast Media Injection System — Trade Name: (1) Contrast Media Injection System Presspro Geo-150 — (2) Dual Shot Gx10
- Recalling firm
- Name of Manufacturer and Distributor: Nemoto Kyorindo Co., Ltd. — Address of Manufacturer and Distributor: 2-12-23 Aoki, Kawaguchi City, Saitama Prefecture — Type of License: Class I Medical...
- Product
- Lot: (1)造影剤注入装置 PRESSPRO GEO-150 製造番号： DAA40231, DAA40232, DAA40233, DAA40234, DAA40237, DAA40238, DAA40239, DAA40240, DAA40241, DAA40242, DAA40243, DAA40244, DAA40245, DAA40246, DAA40247, DAA40248, DAA40249, DAA40250, DAA40251, DAA40252, DAA40253, DAA40254, DAA40255, DAA40256, DAA40257, DAA40258, DAA40259, DAA40260, DAA40261, DAA40262, DAA40263, DAA40264, DAA40265, DAA40266, DAA40267, DAA40268, DAA40269, DAA40270, DAA40271, DAA40272, DAA40273, DAA40274, DAA40275, DAA40276, DAA40277, DAA40278, DAA40279, DAA40280, DAA40281, DAA40282, DAA40283, DAA40284, DAA40285, DAA40286, DAA40287,...
- Reason
- We have discovered an error in the name listed on the regulatory label affixed to this product, which is required for medical devices. Therefore, we will carry out a voluntary recall by applying a new regulatory label with the correct information.
- Classification
- Class III
- 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/fe7bac00-142c-4aab-81fe-d780ffc9a27c