Generic Name: Programmer For Implantable Active Devices (program For Managing Implantable Active Devices) — Trade Name: Ct900 Physician Programmer
- Recalling firm
- Name of Manufacturer/Distributor: Medtronic Japan, Ltd. — Address of Manufacturer/Distributor: 1-2-70 Konan, Minato-ku, Tokyo — License Type: Class I Medical Device Manufacturer/Distributor —...
- Product
- Lot: 対象アプリケーション：A610 対象バージョン：4以下すべてが対象です。 回収対象のアプリケーションをインストールしたCT900医師用プログラマのID： 1488g3fgs8 1blm9f1hdg 1dxlmzwmwv 1qa6fsmxjl 24b2yebu8h 24ktrqk7ze 26bks2xdfv 26ka1rulsm 27thdte2yx 29u7k6llr5 2e93x7ds8g 2fbx1d4tj2 2fjfkp7ph4 2hshcbpq32 2lllq9ntvs 2n4ghtlaqq 2q28ylt83h 2rakzm7xn9 2v1nr2j959 2v7fm5vfy4 2xqk63dpn8 2ztjjzg6a6 336t4wdbh5 34eeqna6tj 34k94r8uyf 36xsh2lkrz 396wdg8za8 39dns94mbf 3agwm5q2cm 3azfz9tfyg 3c52f75urt 3d8gvxnk3a 3dlmvzmaxc 3dqgjkuz5v 3dujgsrt4s 3fqzp4xd4e 3g4xajkzyu 3jap94vkh8 3nj2nhhxpc 3p9j23t4d5 3pmynttefn 3qvpzevzfw 3txmexc3zg 3u67uk8tr4 3uccjx334m 3w7msqv2uz...
- Reason
- An investigation by the overseas manufacturer revealed that three defects related to the deep brain stimulation therapy application (hereinafter referred to as the “DBS app”), which is a component of this product, have occurred. (1) Damage to electronic components of the Percept PC neurostimulator (hereinafter referred to as “Percept PC”) (Note 1) due to cardioversion This issue occurs when cardioversion is performed while the Percept PC is implanted. Due to the effects of cardioversion, electronic components inside the Percept PC may be damaged, causing the device to malfunction and...
- 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/f3727457-6ef1-495b-b3d8-0e6562db810f