Enforcement record

Voluntary Recall disclosure naming 旭化成ゾールメディカル株式会社

旭化成ゾール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 disclosure17 June 2019

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

17 June 2019

RegBase evidence report

Japanese public-record enforcement check

Saveable record of the published action, regulator source, source status, and review notes for internal compliance files.

Report ID: RB-EN-ENFORCEMENT-OTHER-XU-HUA-CHEN-202608182254
Generated at: 19 August 2026 at 07:54
Record URL: https://regbase.jp/en/enforcement/other-xu-hua-cheng-zorumedeikaru-20190617

1. Review Summary

Disclosure name	旭化成ゾールメディカル株式会社	Corporate Number	Not stated in the disclosure
Enforcement record	1 record	Other confirmed records for this company	Outside this report's scope
Action date	17 June 2019	Authority	Ministry of Health, Labour and Welfare
Law	医薬品医療機器等の品質管理等に関する法律	Action type	Voluntary Recall
Source status	Preserved public-source archive recorded

This report summarizes public Japanese government disclosure data held by RegBase. It is not a credit score, sanctions conclusion, legal opinion, or adverse-media determination. Confirm important decisions against the linked official Japanese source.

2. Published Information

Published name	旭化成ゾールメディカル株式会社

3. Enforcement Record

Target name in disclosure	旭化成ゾールメディカル株式会社
Authority	Ministry of Health, Labour and Welfare (厚生労働省)
Law / action type	医薬品医療機器等の品質管理等に関する法律 / Voluntary Recall
Action / announcement date	Action: 17 June 2019 / Announcement: 9 April 2026
English summary	Product names: (1) ZOLL AED Pro semi-automatic defibrillator (2) ZOLL AED Pro semi-automatic defibrillator without manual mode Shipment quantities: (1) 20 units (2) 1 unit Shipment period: from March 5, 2019 to May 31, 2019
Original Japanese text	販売名：（１）ZOLL AED Pro 半自動除細動機（２）ZOLL AED Pro マニュアルモード無し半自動除細動機出荷数量：（１）20台　（２）１台出荷時期：平成31年３月５日～令和元年５月31日
Official source	https://www.mhlw.go.jp/stf/newpage_05256.html
Source archive	https://kiroku.today/a/ab8673582ahgep00
Extraction / evidence timestamps	Extracted: 25 April 2026 at 09:18 / Evidence checked: 25 April 2026 at 09:18 / Archive captured: 12 July 2026 at 16:12

4. Business Location and Permit Details

No additional structured business-location or permit fields are recorded for this disclosure.

5. Other Confirmed Records for This Company

This report covers the single government disclosure shown on this page.

Reviewer Notes

Reviewer		Team / company
Review purpose
Additional notes

□ Official source URL or archived source was checked.
□ Corporate Number, address, or other identifiers were reviewed to avoid confusing similarly named entities.
□ This document is understood as a public-record evidence file, not a credit decision or legal opinion.

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 旭化成ゾールメディカル株式会社

Includes the published name, regulator, governing law, source links, archive status, and reviewer note fields for internal due-diligence files.

Preserved evidence by Kiroku

Review the preserved source for 旭化成ゾールメディカル株式会社

Open the preserved public source with its capture time, original artifact, available verification data, and downloadable evidence pack.

Open preserved source and evidence pack

For developers: JSON integration details

You do not need this for normal browsing. Use it only when integrating this enforcement record into an internal tool or AI workflow.

/api/v1/enforcements?company=%E6%97%AD%E5%8C%96%E6%88%90%E3%82%BE%E3%83%BC%E3%83%AB%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

Open JSON Specs

Action summary

Company: 旭化成ゾールメディカル株式会社Japanese only
Original: 旭化成ゾール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: 17 June 2019
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: (1) ZOLL AED Pro semi-automatic defibrillator (2) ZOLL AED Pro semi-automatic defibrillator without manual mode Shipment quantities: (1) 20 units (2) 1 unit Shipment period: from March 5, 2019 to May 31, 2019

Show original Japanese text

販売名：（１）ZOLL AED Pro 半自動除細動機（２）ZOLL AED Pro マニュアルモード無し半自動除細動機出荷数量：（１）20台　（２）１台出荷時期：平成31年３月５日～令和元年５月31日

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: 2026-04-25T00:18:04.812+00:00
Evidence checked: 2026-04-25T00:18:04.812+00:00
Archive captured: 2026-07-12T07:12:33.83127+00:00

Show audit JSON

{
  "record": {
    "id": "04dd9728-481e-438b-9b9d-b6856d71fb72",
    "url": "https://regbase.jp/en/enforcement/other-xu-hua-cheng-zorumedeikaru-20190617",
    "company_name_original": "旭化成ゾール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": 85,
    "method": "nta_strict_name_nationally_unique",
    "method_label": "nta_strict_name_nationally_unique",
    "notes": "NTA full-download lookup found a nationally unique exact registered-name candidate (旭化成ゾールメディカル株式会社). No Corporate Number was present in the disclosure, so this remains a likely match."
  },
  "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-xu-hua-cheng-zorumedeikaru-20190617",
    "officialSourceUrl": "https://www.mhlw.go.jp/stf/newpage_05256.html",
    "officialDocumentUrl": null,
    "archiveUrl": "https://kiroku.today/a/ab8673582ahgep00",
    "archivedSourceUrl": "https://www.mhlw.go.jp/stf/newpage_05256.html",
    "archiveCapturedAt": "2026-07-12T07:12:33.83127+00:00",
    "extractedAt": "2026-04-25T00:18:04.812+00:00",
    "translatedAt": "2026-05-01T07:06:58.52+00:00",
    "evidenceCheckedAt": "2026-04-25T00:18:04.812+00:00",
    "generatedAt": "2026-08-18T22:54:25.801Z"
  },
  "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.

Language

日本語版を見る (Japanese)

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