{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Milwaukee",
      "address_1": "7865 N 86th St",
      "reason_for_recall": "Mortara Instrument, Inc. has recently become  aware of a potential safety hazard involving our ELI  380 electrocardiograph. When used in a particular  workflow, acquired ECG waveforms for one patient  may become associated with the patient  demographics for a different patient when the  record is transmitted to a records management  system.",
      "address_2": "",
      "product_quantity": "176",
      "code_info": "Serial Number  114470237158  114470237159  114470237163  114470237169  114470237173  114470237176  114470237191  115040243225  115040243448  115040243449  115130250975  115130250976  115130250977  115130250978  115130250979  115130250980  115130250981  115130250982  115130250983  114470237160  114470237165  114470237172  114470237174  114470237178  114470237179  114470237184  114470237185  114470237188  114470237190  114470237161  114470237162  114470237168  114470237177  114470237183  114470237186  114470237187  115040243087  115140252395  115140252396  115150252749  115160253501  114470237164  114470237167  114470237171  114470237175  115040243229  115070245110  114470237166  114470237170  114470237180  114470237181  114470237182  114470237189  114370228740  115110250032  115110250033  115110250034  114110201576  114110201578  115140252393  115140252394  115140252399  115140252397  114360227784  115190256009  115190256010  115190256011  115140252400  115150252442  Serial Number  115170254254  114530241364  115160253238  114530241295  115070245550  115070245551  115100247989  115100247990  115190255287  115030241850  114500239441  115100247699  114510240312  114510240313  115020241387  115030241876  115040243081  114490238052  114490238053  114490238054  114490238055  114490238056  114490238057  114490238058  114490238066  114510240310  115030241851  115030241852  115030241853  115030241854  115030241855  115030241856  115030241857  115030241858  115030241859  115030241860  115030241861  115030241862  115030241863  115030241864  115030241865  115040243079  115040243080  115060244254  115060244255  115060244256  115060244257  115060244258  115160253181  115160253182  115160253183  115190255734  115190255735  115160254106  114510240309  114490238556  114490238557  114490238558  114490238559  114490238560  114490238561  115060244381  115060244382  115060244383  115060244384  115060244385  115140252387  115140252388  115140252389  115040243082  115040243085  115040243086  115120250253  115120250254  115120250255  115120250256  115170254250  115170254251  115170254252  115170254253  114360227772  114360227773  115020241385  115030242164  115120250688  115130250965  115130250966  115130250967  115130250968  114110201950  114110201952  114530241293  114530241294  114530241296  115020241383  115080245620  115110249768  115110249769  115110249770  115110249771  115110249772  115060244864  115160253239  114510240311  115020241384  115020241386  114510240314",
      "center_classification_date": "20150612",
      "distribution_pattern": "Worldwide Distribution - US Distribution to the states of : AZ, CA, FL, GA, IL, MI, NE, SC, UT, WA and WI., and to the countries of : CHINA, PORTUGAL, CANADA, OMAN, MALAYSIA, NEW ZEALAND, INDIA, POLAND, LEBANON, SWITZERLAND, FINLAND, ROMANIA,UNITED ARAB EMIRATES, UNITED KINGDOM, AUSTRALIA, THE NETHERLANDS, ITALY, FRANCE, GERMANY, THAILAND,SAUDI, ARABIA, NORWAY and IRELAND.",
      "state": "WI",
      "product_description": "ELI 380 Electrocardiograph.  The ELI 380 is intended to be a high-performance, multichannel resting electrocardiograph. As a resting electrocardiograph, the ELI 380  simultaneously acquires data from each lead. Once the data is acquired, it can be analyzed, reviewed, stored, printed or transmitted. It is a device  primarily intended for use in hospitals, but may be used in medical clinics and offices of any size.",
      "report_date": "20150624",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Mortara Instrument, Inc",
      "recall_number": "Z-1796-2015",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "71405",
      "termination_date": "20150805",
      "more_code_info": "",
      "recall_initiation_date": "20150529",
      "postal_code": "53224-3431",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}