Generic Name: Semi-automatic Defibrillator — Trade Names: (1) Cu Sp1 — (2) J-pad Cu-sp1
- Recalling firm
- Name of Manufacturer/Distributor: CU Co., Ltd. — Address of Manufacturer/Distributor: 5-7-8 Toyocho, Shinagawa-ku, Tokyo — License Type: Class I Medical Device Manufacturer/Distributor — License...
- Product
- Lot: （１）シーユーＳＰ１ 製造（輸入）数量：5,300台 製造（輸入）年月日：令和元年１２月１６日〜令和３年６月１６日 製造（輸入）出荷年月日：令和２年３月１８日〜令和３年９月２１日 出荷数量：5,300台 （＊)該当ロット： G1R45H101 G1R45H102 G1R45H103 G1R45H104 G1R45H105 G1R45H106 G1R45H107 G1R45H108 G1R4 5H109 G1R45H110 G1R45H111 G1R45H112 G1R45H113 G1R45H114 G1R45H115 G1R45H116 G1R45H117 G1R45H118 G1R4 5H119 G1R45H120 G1R45H121 G1R45H122 G1R45H123 G1R45H124 G1R45H125 G1R45H126 G1R45H127 G1R45H128 G1R4 5H129 G1R45H130 G1R45H131 G1R45H132 G1R45H133 G1R45H134 G1R45H135 G1R45H136 G1R45H137 G1R45H138 G1R4 5H139 G1R45H140 G1R45H141 G1R45H142 G1R45H143 G1R45H144 G1R45H145 G1R45H146 G1R45H147...
- Reason
- Analysis of products provided by the foreign manufacturer revealed that, in specific batches intended for the Japanese market, the self-diagnostic test—which is automatically performed once a day—was not functioning properly and was instead running repeatedly. Since this repeated self-diagnostic testing could lead to premature battery drain, we have decided to conduct a voluntary recall to replace the main circuit board.
- 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/43e45a9d-4ca2-4404-a749-ebef267a8155