Generic Name: Programmer For Implantable Active Devices — Trade Name: Carelink Smartsync Device Manager
CareLink SmartSync Device Manager Recall Summary The CareLink SmartSync Device Manager software for tablets is being recalled because it may cause unintended electrical resets when communicating with Medtronic implantable heart devices, and the "Cancel" button on its EP test screen doesn't work the same way as the older model, leaving limited time to stop high-voltage therapy once started. This affects specific tablet units identified by their manufacturing serial numbers. Medtronic will provide a voluntary software update to fix these issues.
- 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: 本品のモバイルアプリケーション（以下「ソフトウェア」といいます）がダウンロード可能なタブレット端末の 製造番号： C0M7JWX052, C14D912X95, C20R7465D7, C24XCQTW27, C26M6WRMVK, C27D9MQK0H, C2LGY9VWRQ, C2R5HPV6CH, C3F2YFGCWY, C3J2LX4HYQ, C41Q07TNWY, C465QGYGPW, C47Q1VW27V, C4K69VNF2L, C4LCJXMY5V, C4P4Q4WK76, C4X292RVDQ, C4XN79WRCW, C5479X5PQT, C5JY0F3XV2, C5W3641GV3, C66G3RDC96, C66H3YXWH6, C6CR22F59F, C6W047R40X, C7295J995F, C74FWWW00N, C77QP37VKP, C7M2PW3N63, C7WRM2K60G, C9499T3D36, C94K4QFYVR, C979TXM3VP, C9CVYMWTJ9, C9F7LH252C, C9GP9Q15W2, C9NFJDXK77, C9NT29DFNV, CC73N4JQYG, CCWH0FXP6Y, CCX9T01292, CCXDKFJ4XY, CD212YFW3Q, CDF21HH009,...
- Reason
- We have received a report from the overseas manufacturer that a message may appear indicating that an unintended electrical reset occurred when this product communicated with Medtronic implantable devices. Furthermore, it has been determined that the specifications of the “Cancel” button on the EP test screen differ from those of the CareLink 2090W (Medical Device Approval Number: 21900BZX00423000), and that the time available to cancel high-voltage therapy once it has been initiated is limited with this product. To address these issues, we will implement a voluntary software update for...
- 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/da058bde-27b6-436e-b4af-1bf6713aa3bd