Generic Name: Surgical Robot System — Trade Name: Mako System
- Recalling firm
- Name of Manufacturer and Distributor: Nippon Stryker Co., Ltd. — Address of Manufacturer and Distributor: 1-1 Nishi-Shinjuku 5-chome, Shinjuku-ku, Tokyo — License Type: Class I Medical Device...
- Product
- Lot: 以下のアプリケーションソフトウェア(DVDディスク)を用いてインストールしたMAKO 3.0/3.1 ロボティックアー ムが対象です。 アプリケーションソフトウェア ・TKA 2.0 THA 4.1 PKA 3.0 FOR 3.1 カタログ番号：700001590414、 ロット番号：9041407 ・MAKO ソフトウェアアップデート CD TKA 2.0 + TKA 1.0.1 + THA 4.0 + PKA 3.0 カタログ番号：700001590415、ロット番号：9041513, 1000415 自主改修対象機器 構成品名：MAKO 3.0 ロボティックアーム -MICS 品番：209999 対象シリアル番号：544, 666, 669, 824 対象台数：4台 構成品名：MAKO 3.1 ロボティックアーム 品番：2199999 対象シリアル番号：825, 853, 885, 935, 948, 992, 994, 1069, 1072,1095, 1116, 1119, 1124, 1270,1343, 1346, 1406, 1442, 1443, 1444, 1500, 1502, 1503, 1520, 1543, 1548, 1606, 1627, 1632, 1634, 1649, 1691, 1713, 1735, 1812, 1813,...
- Reason
- It has been confirmed both domestically and internationally that Software Error #3 may occur in the “MAKO 3.0 Robotic Arm -MICS” and “MAKO 3.1 Robotic Arm”—components of the Mako System, a surgical assistance robot for joint replacement—if the Mako System is not restarted before switching between the installed application software described in Section 2. If Software Error #3 occurs, the Mako System will lock as a safety measure and become inoperable. An application software update is required to resolve this issue. Therefore, we will implement a voluntary recall.
- 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/89eddf17-a98e-4570-8d7f-36cb994beac9