{
  "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,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "192369",
      "product_res_number": "Z-0827-2022",
      "event_date_initiated": "2022-02-01",
      "event_date_created": "2022-03-25",
      "recall_status": "Open, Classified",
      "res_event_number": "89758",
      "product_code": "LHN",
      "k_numbers": [
        "K120676",
        "K172848"
      ],
      "product_description": "Mevion S250 and S250i Proton Therapy Systems hand pendant (P/N 10263 or P/N 37808)",
      "code_info": "All theryapy systems, all hand pendant serial numbers.  Therapy system UDI 00864366000100 and UDI 00864366000124.",
      "firm_fei_number": "3007087027",
      "recalling_firm": "Mevion Medical Systems, Inc.",
      "address_1": "300 Foster St",
      "city": "Littleton",
      "state": "MA",
      "postal_code": "01460-2017",
      "additional_info_contact": "Mevion Customer Service\n978-540-1500",
      "reason_for_recall": "Malfunction of the hand pendant controlling movement of the therapy couch and nozzle may result in unintentional motion. Patient injury is possible if they come in contact with the nozzle or other objects in the treatment room.",
      "root_cause_description": "Component design/selection",
      "action": "Mevion has voluntarily recalled Hand Pendants for S250 and S250i Proton Therapy Systems. All  distributed Hand Pendants have been inspected for the identified defect and those that failed inspection have been removed from service following technical service bulletin TSB0048. Subsequent Urgent Medical Device Recall Notice dated 02/11/2022 was hand delivered by on-site field service engineers.  Customers are instructed to complete and return the acknowledgement receipt.  Please contact Mevion Customer service (robyn.walker@mevion.com) with any questions or concerns.",
      "product_quantity": "39 (36 US, 3 OUS)",
      "distribution_pattern": "Worldwide distribution - US Nationwide distribution in the states of FL, MO, NJ, OH, OK, UT, DC and the country of Netherlands.",
      "openfda": {
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        "registration_number": [
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          "2032229",
          "8043933",
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          "1038814",
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          "9681124",
          "8031557",
          "3005374502"
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        "fei_number": [
          "1270485",
          "3008328959",
          "3003993895",
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        ],
        "device_name": "System, Radiation Therapy, Charged-Particle, Medical",
        "medical_specialty_description": "Radiology",
        "regulation_number": "892.5050",
        "device_class": "2"
      }
    }
  ]
}