{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-09-12",
    "results": {
      "skip": 0,
      "limit": 1,
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  "results": [
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      "cfres_id": "215824",
      "product_res_number": "Z-2673-2025",
      "event_date_initiated": "2025-09-09",
      "event_date_posted": "2025-09-30",
      "recall_status": "Open, Classified",
      "res_event_number": "97509",
      "product_code": "NFJ",
      "k_numbers": [
        "K200132"
      ],
      "product_description": "Ashvins variant HEYEX 2 / HEYEX PACS. Software Version: Version 2.6.0 (Build 2088) to 2.6.8 (Build 2220).\r\n\r\nDevice Type: Software (Medical Image Management, Picture Archiving and Communication System)",
      "code_info": "Model Name: Ashvins variant HEYEX 2 / HEYEX PACS. UDI-DI: 4260648620046. Software Version: 2.6.0 (Build 2088) to 2.6.8 (Build 2220).",
      "firm_fei_number": "3003995303",
      "recalling_firm": "MedicalCommunications GmbH",
      "address_1": "Max-Jarecki-Str. 8 8 max-jarecki-str.",
      "city": "Heidelberg",
      "country": "Germany",
      "additional_info_contact": "Kenneth Barron\nUS-800-931-2230",
      "reason_for_recall": "Potential that the measured value may be smaller than the actual area.",
      "root_cause_description": "Software design",
      "action": "Ashvins notified consignees on about 09/09/2025 via emailed letter. Consignees were instructed to cease using the freeform measurement function in the MMV until the software update has been performed, which is now available.  Consignees were instructed to perform the update as soon as possible, complete the digital Field Safety Notice Acknowledgement and Receipt Form, and maintain a copy of the letter and the user manual with the device until the software update is complete.",
      "product_quantity": "474 units",
      "distribution_pattern": "US Nationwide distribution.",
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        "device_name": "System, Image Management, Ophthalmic",
        "medical_specialty_description": "Radiology",
        "regulation_number": "892.2050",
        "device_class": "2"
      }
    }
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}