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: 対象モデル：A71100 対象バージョン：v1.0.4255, v1.0.4488 本アプリケーションがダウンロードされたタブレットのID： F8NG83MW8N 1488g3fgs8 1blm9f1hdg 1dxlmzwmwv 1FDKUY556N 1FRLYU1CRB 1JZWAWW4EV 1PVUN3VJ3G 1S3RTV8JVQ 21TZ8C6LW7 24kkjpre4m 24ktrqk7ze 25G9H1M9C3 29u7k6llr5 2DTQDBHJYM 2E7GPHKGN6 2e93x7ds8g 2F7EVR42MK 2fbx1d4tj2 2h5x72hnus 2MKG2JHQV5 2n4f2mvh3m 2NBZYBTLSU 2Q6SG8F2Z9 2T5AZDZ281 2UFBFHXF2U 2v1nr2j959 2v7fm5vfy4 2ztjjzg6a6 313L5E6CZV 34eeqna6tj 34k94r8uyf 36xsh2lkrz 39hyc9qyt3 3agwm5q2cm 3azfz9tfyg 3cqccfvr7z 3d8gvxnk3a 3dlmvzmaxc 3g4xajkzyu 3jwqd5bcsz 3n6fpgb2jl 3nj2nhhxpc 3pmynttefn 3TYZSHX823 3u67uk8tr4 3uccjx334m...
- Reason
- We are conducting a voluntary update to the CT900 Physician Programmer on which the "A71100 Restore Physician Programmer Application" (hereinafter referred to as the "Restore App") is installed—which may experience the issue described below—to a version of the Restore App that resolves this issue. [Summary of the Issue] In versions of the Restore App prior to v1.0.4489, there is a possibility that a device reset message may not be cleared. A device reset can occur for various reasons, such as when the stimulator’s (Note 1) battery is over-discharged. While it is typically cleared during 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/9ab7bd66-ed43-44c7-9273-3bdee83b3d37