{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
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  },
  "results": [
    {
      "cfres_id": "117004",
      "product_res_number": "Z-0833-2015",
      "event_date_initiated": "2013-04-19",
      "event_date_posted": "2014-12-19",
      "recall_status": "Terminated",
      "event_date_terminated": "2016-06-10",
      "res_event_number": "64760",
      "product_code": "LMB",
      "product_description": "Centricity Enterprise Archive is a software product for receiving, archiving and sending of medical data. DICOM devices (e..g. modalities, workstations) Communicate with the archive using the DICOM protocol (published by ACR-NEMA). The clinical use is limited to the interaction that other systems have with the Centricity Enterprise archive. The intended users for Centricity Enterprise  Archive are service personnel and system administrators and non clinical users. As of V4.0 XDS enabled systems can communicate with the archive using the XDS and XDS-1 profiles (published by IHE).",
      "code_info": "Centricity Enterprise Archive versions: 4.0.x",
      "firm_fei_number": "3004526608",
      "recalling_firm": "Ge Healthcare It",
      "address_1": "540 W Northwest Hwy",
      "city": "Barrington",
      "state": "IL",
      "postal_code": "60010-3051",
      "additional_info_contact": "GE Remote Online Center\n800-437-1171",
      "reason_for_recall": "GE Healthcare has become aware of a potential data loss issue associated with empty path names resulting from HL-7 updates when the cache disk is almost full.",
      "root_cause_description": "Software design",
      "action": "General Electric sent an Urgent Medical Device Correction letter dated April 19, 2013, to all affected customers. The letter instructs customers to ensure that Enterprise Archive partitions have enough free space available, in particular the cache disk should have at least 10% free space available. This could be facilitated by setting appropriate disk limits and watermarks on the individual libraries in Enterprise Archive. In case the disks are not being purged to the configured watermarks and the cache disk is almost full, customers are requested to contact their local GE service person.\nA permanent product correction will be provided to all customers under FMI85209R.\nCustomers with questions were instructed to contact their local Sales/Service Representative.  Also the Remote Online Center (ROC) Customer Care can be reached at 1-800-437-1171.",
      "product_quantity": "115 units",
      "distribution_pattern": "Nationwide Distribution including  AZ, OH, WA.",
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        "device_name": "Device, Digital Image Storage, Radiological",
        "medical_specialty_description": "Radiology",
        "regulation_number": "892.2010",
        "device_class": "1"
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    }
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}