Generic Name: Program For Managing Implantable Active Devices — Trade Name: Ct900 Physician Programmer
- Recalling firm
- Name of Manufacturer and Distributor: Medtronic Japan Co., Ltd. — Address of Manufacturer and Distributor: 1-2-70 Konan, Minato-ku, Tokyo — Type of License: Class I Medical Device Manufacturer and...
- Product
- Lot: モデル番号：A71200 バージョン：v2.0.2465, v2.0.2683 シリアル（数量418個(*)）： 1488g3fgs8 1blm9f1hdg 1dxlmzwmwv 1FDKUY556N 1FRLYU1CRB 1JZWAWW4EV 1PVUN3VJ3G 1USN282VPM 21TZ8C6LW7 29u7k6llr5 2DTQDBHJYM 2e93x7ds8g 2F7EVR42MK 2fbx1d4tj2 2MKG2JHQV5 2n4f2mvh3m 2Q6SG8F2Z9 2T5AZDZ281 2v1nr2j959 313L5E6CZV 39hyc9qyt3 3agwm5q2cm 3azfz9tfyg 3cqccfvr7z 3d8gvxnk3a 3dlmvzmaxc 3jwqd5bcsz 3pmynttefn 3uccjx334m 3XSV8DGTPH 3zd56m7tzs 419ue3lg1c 4336jdlz48 46VUKMDP4A 48trb8sj83 4bns63jsvn 4cqsz948kp 4e5lp77e7g 4esfjasd5h 4ey9a2kx42 4f84c9nttx 4fzqk89kjq 4khbsddh4w 4m4ugh6gsy 4nzpk89vs7 4q7bwmy92e 4rlp3t71v8 4vyqpc4eqj...
- Reason
- In versions v2.0.2465 and v2.0.2683 of the “A71200 Vanta Physician Programmer Application” (hereinafter referred to as the “Vanta App”), a malfunction may occur where a system error message requesting a restart of the application is displayed if the [Start Using] button is selected multiple times in the Vanta App during the initial programming of a connected stimulation device (Note 1). When communication with the stimulator is resumed after restarting the application, the Vanta App displays a “Validation Error” message. This message offers two options: [End Workflow] and [Continue]. If...
- 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/7a18df7e-5d04-499f-95dc-cdea1d19432e