Enforcement record

Voluntary Recall disclosure naming セント・ジュード・メディカル株式会社

セント・ジュード・メディカル株式会社 (医薬品医療機器等の品質管理等に関する法律)

This page records one action from a Japanese government disclosure, including the published name, governing law, authority, action details, and official source.

医薬品医療機器等の品質管理等に関する法律Ministry of Health, Labour and WelfareGovernment disclosure22 August 2014

Action type

Voluntary Recall

Law

医薬品医療機器等の品質管理等に関する法律

Authority

Ministry of Health, Labour and Welfare

Action date

22 August 2014

Current page: Enforcement record

This screen focuses on one disclosed action: the published name, governing law, authority, facts, source status, and review evidence.

Free report

Save the disclosure record naming セント・ジュード・メディカル株式会社

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Preserved evidence by Kiroku

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Open preserved source and evidence pack
For developers: JSON integration details

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/api/v1/enforcements?company=%E3%82%BB%E3%83%B3%E3%83%88%E3%83%BB%E3%82%B8%E3%83%A5%E3%83%BC%E3%83%89%E3%83%BB%E3%83%A1%E3%83%87%E3%82%A3%E3%82%AB%E3%83%AB%E6%A0%AA%E5%BC%8F%E4%BC%9A%E7%A4%BE&limit=10

Action summary

Company
セント・ジュード・メディカル株式会社Japanese only
Original: セント・ジュード・メディカル株式会社
Governing law
医薬品医療機器等の品質管理等に関する法律
医薬品医療機器等の品質管理等に関する法律
Action type
Voluntary Recall
自主回収
Action date
22 August 2014
Issuing authority
Ministry of Health, Labour and Welfare
厚生労働省
Industry context
医療機器

Violation

Machine-translated summary — verify against original

Product names of implantable automatic defibrillators: Elypse Limited (models CD1277-36, CD1277-36Q, CD2277-36, CD2277-36Q), Elypse (models CD1377-36, CD1377-36C, CD1377-36Q, CD1377-36QC, CD2377-36, CD2377-36C, CD2377-36Q, CD2377-36QC), Nutrin ICD Limited (models CD1293-36, CD1293-36Q, CD2293-36, CD2293-36Q), Nutrin ICD (models CD1393-36, CD1393-36C, CD1393-36Q, CD1393-36QC, CD2393-36, CD2393-36C, CD2393-36Q, CD2393-36QC).

Show original Japanese text

自動植込み型除細動器の製品名:エリプス Limited(モデルCD1277-36、CD1277-36Q、CD2277-36、CD2277-36Q)、エリプス(モデルCD1377-36、CD1377-36C、CD1377-36Q、CD1377-36QC、CD2377-36、CD2377-36C、CD2377-36Q、CD2377-36QC)、ニュートリノICD Limited(モデルCD1293-36、CD1293-36Q、CD2293-36、CD2293-36Q)、ニュートリノICD(モデルCD1393-36、CD1393-36C、CD1393-36Q、CD1393-36QC、CD2393-36、CD2393-36C、CD2393-36Q、CD2393-36QC)

Compliance context

Context needed

This is a public Japanese regulatory disclosure. The exact legal effect depends on the cited source and regulator.

Japanese regulatory disclosure under 医薬品医療機器等の品質管理等に関する法律.

Review the original Japanese source and determine relevance to your counterparty-risk workflow.

This context is an operational aid for review workflows, not a credit opinion or legal conclusion.

Evidence pack

Original Ministry of Health, Labour and Welfare source (Japanese)Open preserved source and evidence pack
Extracted at
2026-04-25T00:06:59.831+00:00
Evidence checked
2026-04-25T00:06:59.831+00:00
Archive captured
2026-07-12T06:51:09.458574+00:00
Show audit JSON
{
  "record": {
    "id": "0eeeabaf-987b-4e4f-a567-bb78b08fb225",
    "url": "https://regbase.jp/en/enforcement/other-sentoziyudomedeikaru-20140822",
    "company_name_original": "セント・ジュード・メディカル株式会社",
    "company_name_registry": null,
    "corporate_number": null,
    "law": {
      "ja": "医薬品医療機器等の品質管理等に関する法律",
      "en": "医薬品医療機器等の品質管理等に関する法律"
    },
    "action_type": {
      "ja": "自主回収",
      "en": "Voluntary Recall"
    },
    "authority": {
      "ja": "厚生労働省",
      "en": "Ministry of Health, Labour and Welfare"
    }
  },
  "entity_match": {
    "status": "unresolved",
    "confidence": 60,
    "method": "extracted_japanese_name",
    "method_label": "Company name extracted from the Japanese public disclosure",
    "notes": "The linked company profile has not been verified under the current identity policy."
  },
  "review": {
    "status": "unreviewed",
    "label": "Machine extracted"
  },
  "compliance_context": {
    "severity": "Context needed",
    "actionMeaning": "This is a public Japanese regulatory disclosure. The exact legal effect depends on the cited source and regulator.",
    "practicalNote": "Review the original Japanese source and determine relevance to your counterparty-risk workflow.",
    "lawContext": "Japanese regulatory disclosure under 医薬品医療機器等の品質管理等に関する法律."
  },
  "evidence": {
    "recordUrl": "https://regbase.jp/en/enforcement/other-sentoziyudomedeikaru-20140822",
    "officialSourceUrl": "https://www.mhlw.go.jp/stf/houdou/0000055280.html",
    "officialDocumentUrl": null,
    "archiveUrl": "https://kiroku.today/a/17ee52526fhfox1z",
    "archivedSourceUrl": "https://www.mhlw.go.jp/stf/houdou/0000055280.html",
    "archiveCapturedAt": "2026-07-12T06:51:09.458574+00:00",
    "extractedAt": "2026-04-25T00:06:59.831+00:00",
    "translatedAt": "2026-05-01T06:57:08.766+00:00",
    "evidenceCheckedAt": "2026-04-25T00:06:59.831+00:00",
    "generatedAt": "2026-08-18T22:53:28.029Z"
  },
  "limitations": [
    "RegBase aggregates public Japanese government disclosures and does not provide a credit opinion.",
    "English summaries are provided for reference. The original Japanese source is authoritative.",
    "Possible or unresolved entity matches should be manually verified before use in a decision."
  ]
}

The original Japanese disclosure is the authoritative record. Use possible or unresolved matches only as leads for manual review.

About this recordAggregated and translated from public Japanese government disclosures. The English text is for reference only — authoritative content is the linked Japanese source.