{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Twinsburg",
      "state": "OH",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "87493",
      "recalling_firm": "Hitachi Medical Systems America Inc",
      "address_1": "1959 Summit Commerce Park",
      "address_2": "N/A",
      "postal_code": "44087-2371",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide distribution in the state of TX.",
      "recall_number": "Z-1282-2021",
      "product_description": "Ultrasonic pulsed doppler imaging system - Product Usage: intended for use by trained personnel (doctor, Sonographer, etc.) for the diagnostic ultrasound evaluation of Fetal, Abdominal, Intra-operative (Spec.), Intraoperative (Neuro.), Laparoscopic, Pediatric, Small Organ (Spec.), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-esoph. (non-Card.), Musculo-skel. (Convent.), Musculo-skel. (Superfic.), Wound (Cavernous/Non-Cavernous), Gynecology, Cardiac Adult, Cardiac Pediatric, Trans-esophageal (card.), Peripheral vessel, Endoscopy clinical applications.",
      "product_quantity": "1",
      "reason_for_recall": "Arietta 850 software version 4.0.0., 4.0.1, and 4.0.2 has an error in the focus point and transducer aperture settings in the SWE function. When the affected software with SWE function is used in conjunction with the C252 probe, this error can result in out of specification MI/TI acoustic output. The MI/TI acoustic output is higher than regulatory limits.",
      "recall_initiation_date": "20210301",
      "center_classification_date": "20210319",
      "termination_date": "20211104",
      "report_date": "20210331",
      "code_info": "Asset Tag: U8AR0479    Arietta 850 software version 4.0.0., 4.0.1, and 4.0.2",
      "more_code_info": ""
    }
  ]
}