{"data":[{"id":"9e176f56-ffc7-42b6-809a-47293025899f","company_name":"日本メドトロニック株式会社","company_name_en":null,"corporate_number":"9010401064015","authority":"厚生労働省","law_name":"医薬品医療機器等法","action_type":"業務改善命令","action_date":"2024-11-08","announcement_date":"2026-04-01","violation_summary":"日本メドトロニック株式会社が製造販売する医療機器（「インスリンポンプ　注入セット」）について、副作用等報告義務の対象となる外国医療機器の不具合症例が定められた期限内に報告されていなかったことが確認されました。","violation_summary_en":"It was confirmed that Medtronic Japan Co., Ltd. did not report adverse event cases related to their medical device (Insulin Pump Injection Set), which are subject to reporting obligations for foreign medical devices, within the specified deadline.","penalty_amount":null,"is_verified":false,"source_url":"https://www.mhlw.go.jp/stf/newpage_45109.html","url":"https://regbase.jp/enforcement/other-ri-ben-medotoronituku-20241108"},{"id":"96f35f1d-4886-41a1-ab78-1e3f6dd6c900","company_name":"日本メドトロニック株式会社","company_name_en":null,"corporate_number":"9010401064015","authority":"厚生労働省","law_name":"医療機器の自主回収について（クラスⅠ）","action_type":"自主回収","action_date":"2021-12-24","announcement_date":"2026-04-01","violation_summary":"東京都より、別添のとおり、日本メドトロニック株式会社が下記の医療機器の自主回収に着手した旨の情報提供がなされましたので、お知らせいたします。","violation_summary_en":"Tokyo Metropolitan Government provided information that Japan Medtronic Co., Ltd. has initiated a voluntary recall of the medical devices listed below.","penalty_amount":null,"is_verified":false,"source_url":"https://www.mhlw.go.jp/stf/newpage_23042.html","url":"https://regbase.jp/enforcement/other-ri-ben-medotoronituku-20211224"},{"id":"dfc44cfb-0eae-4b6c-bf67-756aba0b2c6c","company_name":"日本メドトロニック株式会社","company_name_en":null,"corporate_number":"9010401064015","authority":"厚生労働省","law_name":"医療機器の自主回収に関する規定","action_type":"業務停止命令","action_date":"2021-02-18","announcement_date":"2026-03-31","violation_summary":"東京都より、日本メドトロニック株式会社が下記の医療機器の自主回収に着手した旨の情報提供がなされました。","violation_summary_en":"Information was provided that Medtronic Japan Co., Ltd. has initiated a voluntary recall of the following medical device by Tokyo Metropolitan Government.","penalty_amount":null,"is_verified":false,"source_url":"https://www.mhlw.go.jp/stf/newpage_16831.html","url":"https://regbase.jp/enforcement/other-ri-ben-medotoronituku-20210218"},{"id":"73559636-3967-4f5c-9ab3-0abfcfe02380","company_name":"日本メドトロニック株式会社","company_name_en":null,"corporate_number":"9010401064015","authority":"厚生労働省","law_name":"医薬品医療機器等法","action_type":"自主回収","action_date":"2019-06-11","announcement_date":"2026-04-09","violation_summary":"東京都より、日本メドトロニック株式会社が下記の医療機器の自主回収に着手した旨の情報提供がなされました。","violation_summary_en":"The Tokyo Metropolitan Government provided information that Japan Medtronic Co., Ltd. has initiated a voluntary recall of the following medical device.","penalty_amount":null,"is_verified":false,"source_url":"https://www.mhlw.go.jp/stf/newpage_05189.html","url":"https://regbase.jp/enforcement/other-ri-ben-medotoronituku-20190611"},{"id":"816a8bb8-ec5a-4502-afd6-e87ca3344dc4","company_name":"日本メドトロニック株式会社","company_name_en":null,"corporate_number":"9010401064015","authority":"厚生労働省","law_name":"医薬品医療機器等の品質管理等に関する法律","action_type":"自主回収","action_date":"2019-02-04","announcement_date":"2026-03-30","violation_summary":"東京都より、平成31年１月18日付けで日本メドトロニック株式会社が自主回収に着手した医療機器について、別添のとおり、自主回収を行う製品及び製造番号が追加となった旨の情報提供がなされましたので、お知らせいたします。","violation_summary_en":"On January 18, 2019, Tokyo Metropolitan Government was informed that Japan Medtronic Co., Ltd. has initiated a voluntary recall of certain medical devices. Additional products and serial numbers have been included in the recall as detailed in the attached information.","penalty_amount":null,"is_verified":false,"source_url":"https://www.mhlw.go.jp/stf/newpage_03529.html","url":"https://regbase.jp/enforcement/other-ri-ben-medotoronituku-20190204"},{"id":"25a68774-b597-4e86-97b4-df854d34993e","company_name":"日本メドトロニック株式会社","company_name_en":null,"corporate_number":"9010401064015","authority":"厚生労働省","law_name":"医療機器の自主回収に関する規定","action_type":"業務停止命令","action_date":"2019-01-18","announcement_date":"2026-04-09","violation_summary":"東京都より、別添のとおり日本メドトロニック株式会社が下記の医療機器の自主回収に着手した旨の情報提供がなされましたので、お知らせいたします。","violation_summary_en":"The Tokyo Metropolitan Government has provided information that Japan Medtronic Co., Ltd. has initiated a voluntary recall of certain medical devices as detailed in the attached document.","penalty_amount":null,"is_verified":false,"source_url":"https://www.mhlw.go.jp/stf/newpage_03285.html","url":"https://regbase.jp/enforcement/other-ri-ben-medotoronituku-20190118"}],"meta":{"query":null,"corporate_number":"9010401064015","law":null,"authority":null,"action_type":null,"count":6,"api_docs":"https://regbase.jp/api-docs","openapi_schema":"https://regbase.jp/api/openapi.json","llms":"https://regbase.jp/llms.txt","usage_note":"Use RegBase for targeted public-source screening of Japanese companies and enforcement records. Absence of returned records is not a clearance, legal opinion, sanctions result, or credit decision.","rate_limit":{"limit":10,"window_seconds":60,"remaining":5,"reset_at":"2026-05-20T07:10:49.045Z"},"daily_rate_limit":{"limit":300,"window_seconds":86400,"remaining":130,"reset_at":"2026-05-21T07:09:49.045Z"}}}