{
  "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,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "121539",
      "product_res_number": "Z-0141-2014",
      "event_date_initiated": "2013-08-15",
      "event_date_posted": "2013-11-06",
      "recall_status": "Terminated",
      "event_date_terminated": "2014-04-28",
      "res_event_number": "66138",
      "product_description": "Harmony Equipment Management System, Model #603X/80XX, STERIS Corporation, Mentor, OH\r\n\r\nHarmony Equipment Management Systems (EMS) are used in hospital facilities to provide ready access to medical gasses, electrical power and audio/visual data services, in addition to managing surgical support equipment such as endoscopic equipment, cautery devices and insufflators.",
      "code_info": "Serial numbers 0422503114 - 0426604096",
      "firm_fei_number": "1527821",
      "recalling_firm": "Steris Corporation",
      "address_1": "5960 Heisley Rd",
      "city": "Mentor",
      "state": "OH",
      "postal_code": "44060-1834",
      "additional_info_contact": "Lindsey M. McGowan\n440-392-7519",
      "reason_for_recall": "Drger Medical GmbH has notified STERIS of the potential for a break in the drive screw contained in the motorized ceiling supply unit, a component of the Harmony EMS system.  The ceiling supply unit controls the motorized adjustment of the height and rotation of the supply column.  Should a break occur in the drive screw, there is potential for the adjustable arm to drop down, causing the EMS sys",
      "root_cause_description": "Component design/selection",
      "action": "STERIS sent an Urgent Voluntary Field Correction Notice dated August 15, 2013, to all affected customers.  The letter identified the product the problem and the action needed to be taken by the customer.\r\n\r\nSTERIS action- Drager Medical has provided STERIS instructions for inspection of the alignment of the mounting plate of the motor unit. If it is found that the mounting plate is bent, the drive screw within the motor unit must be replaced.  STERIS will visit your facility to inspect the motorized ceiling supply unit of your Harmony EMS system(s) and if damage is observed, will replace the drive screw within the motor unit.  For further information or if you have any questions regarding our visit to your facility, please contact STERIS Field Service  Dispatch at 1-800-333-8828.",
      "product_quantity": "127 units",
      "distribution_pattern": "Nationwide distribution: USA including the states of Alabama, Arkansas, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Texas, Virginia, Washington and Wisconsin.",
      "openfda": {}
    }
  ]
}