{
  "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": "Bothell",
      "state": "WA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "81134",
      "recalling_firm": "Philips Electronics North America Corp.",
      "address_1": "22100 Bothell Everett Hwy",
      "address_2": "N/A",
      "postal_code": "98021-8431",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution - U.S Nationwide in the states of:  GA, MO, IN, FL, NY, HI, CA, LA, WA, IL, NE;    Foreign (OUS):Australia, Austria,Belgium, Canada, France, Germany, Hong Kong, Italy, Japan, Kazakhstan, Netherlands, Norway, Spain, Switzerland, Taiwan, United Kingdom",
      "recall_number": "Z-0175-2019",
      "product_description": "Philips HeartStart FR3 Defibrillator, Model: 861388, 861389    Product Usage:  The HeartStart FR3 is used to treat suspected victims of ventricular fibrillation (VF), the most common cause of sudden cardiac arrest (SCA), and certain ventricular tachycardia (VTs). Both models are used with disposable pads applied to potential victims of SCA with the following symptoms: 1) Unresponsiveness 2) Absence of normal breathing The HeartStart FR3 is intended for adults and children over 55 pounds (25kg) or 8 years old. Both models 861388 and 861389 are also intended for children under 55 pounds (25kg) or 8 years old when used with the optional Infant/Child Key. If the Infant/Child Key is not available, or you are uncertain of the child s age or weight, do not delay treatment. Device not sterile and not implantable.",
      "product_quantity": "432",
      "reason_for_recall": "Automated external defibrillators may not fully meet IPx5 water ingress specification. The device may fail to function should water intrusion occur.",
      "recall_initiation_date": "20181010",
      "center_classification_date": "20181017",
      "termination_date": "20220819",
      "report_date": "20181024",
      "code_info": "Serial Numbers of affected AEDs begin with C16J, C16K, C17A, or C17B.    Serial Numbers: C17B-00171    C17A-01227  C17A-01349  C17A-01361  C17B-00322  C17B-00323  C17B-00360  C17B-00172  C16K-01024  C17A-01356  C17A-01382  C17B-00038  C17A-01152  C16K-00726  C17A-01154  C17B-00101  C17B-00102  C17B-00104  C17B-00105  C17B-00107  C17B-00109  C17B-00110  C17B-00111  C17B-00112  C17B-00113  C17B-00114  C17B-00115  C17B-00116  C17B-00117  C17B-00118  C17B-00119  C17B-00125  C17B-00127  C17B-00132  C17B-00133  C17B-00143  C17B-00145  C17B-00158  C17B-00159  C17B-00160  C17B-00163    C16K-00495  C16K-00952  C16K-01029  C17B-00025  C17B-00057  C17B-00059  C17B-00069  C17B-00070  C17B-00071  C17B-00074  C17B-00077  C17B-00082  C17B-00083  C17B-00084  C17B-00089  C17B-00090  C17B-00098  C17B-00173  C17B-00178  C17B-00324  C17B-00120  C17B-00122  C17B-00123  C17B-00124  C17B-00126  C17B-00128  C17B-00129  C17B-00130  C17B-00131  C17B-00134  C17B-00135  C17B-00136  C17B-00137  C17B-00138  C17B-00139  C17B-00140  C17B-00141  C17B-00149  C17B-00150  C17B-00151  C17B-00152  C17B-00153  C17B-00154  C17B-00155  C17B-00156  C17B-00161  C17B-00167  C17B-00169  C17B-00170  C17B-00174  C17B-00175  C17B-00176  C17B-00177  C17B-00179  C17B-00181  C17B-00183  C17B-00185  C17B-00186  C17B-00188  C17B-00189  C17B-00191  C17B-00192  C17B-00193  C17B-00194  C17B-00195  C17B-00196  C17B-00197  C17B-00198  C17B-00199  C17B-00200  C17B-00201  C17B-00202  C17B-00203  C17B-00204  C17B-00206  C17B-00207  C17B-00209  C17B-00210  C17B-00213  C17B-00215  C17B-00216  C17B-00218  C17B-00219  C17B-00223  C17B-00225  C17B-00226  C17B-00227  C17B-00228  C17B-00229  C17B-00232  C17B-00240  C17B-00243  C17B-00244  C17B-00245  C17B-00246  C17B-00247  C17B-00248  C17B-00255  C17B-00256  C17B-00257  C17B-00258  C17B-00259  C17B-00260  C17B-00261  C17B-00263  C17B-00264  C17B-00265  C17B-00266  C17B-00277  C17B-00278  C17B-00283  C17B-00287  C17A-01261  C17A-01262  C17A-01263  C17A-01265  C17A-01277  C17A-01292  C17A-01293  C17A-01295  C17A-01341  C17A-01343  C17A-01351  C17A-01354  C17A-01355  C17A-01357  C17A-01359  C17A-01360  C17A-01362  C17A-01366  C17A-01368  C17A-01371  C17A-01372  C17A-01376  C17A-01377  C17A-01384  C17A-01385  C17A-01386  C17B-00014  C17B-00015  C17B-00026  C17B-00029  C17B-00043  C17B-00044  C17B-00095  C17B-00166  C17B-00100  C16K-00497  C17B-00087  C17A-00833  C17A-00834  C17A-00835  C17A-00837  C17A-00838  C17A-00839  C17A-00840  C17A-00841  C17A-00842  C17A-00843  C17A-00844  C17A-00845  C17A-00846  C17A-00847  C17A-00848  C17A-00849  C17A-00852  C17A-00853  C17A-00854  C17A-00855  C17A-00856  C17A-00857  C17A-00858  C17A-00860  C17A-00881  C17A-00882  C17A-00883  C17A-00884  C17A-00885  C17A-00887  C17A-00888  C17A-00889  C17A-00890  C17B-00339  C17B-00344  C17B-00335  C17B-00345  C16J-01286  C17B-00329    C17B-00292  C17B-00293  C17B-00313  C17B-00317  C17B-00320  C17A-01267  C16K-00944  C17A-01297  C17B-00060  C17B-00062  C17B-00063  C17B-00078  C17B-00088  C17B-00092  C17B-00096  C17B-00299  C17B-00306  C17B-00321  C17B-00338  C17B-00359  C17B-00361  C17B-00362  C17B-00364  C17B-00367  C17B-00371  C17B-00373  C17B-00374  C17B-00375  C17B-00386  C17B-00387  C17B-00388  C17B-00389  C17B-00392  C17B-00393  C17B-00394  C17B-00395  C17B-00396  C17B-00398  C17B-00399  C17B-00400  C17B-00235  C17A-01381  C17B-00056  C17B-00289  C17B-00291  C17A-01342  C17A-01344  C17A-01358  C17A-01383  C17B-00013  C17B-00033  C17B-00302  C17B-00220  C17B-00308  C17B-00341  C17B-00030  C17B-00239  C16K-00790  C17B-00034  C17B-00085  C17B-00332  C17B-00334  C17B-00336  C17B-00343  C17B-00350  C17B-00351  C17B-00354  C17B-00355  C17B-00356  C17B-00357  C17B-00365  C17B-00369  C17B-00376  C17B-00378  C17B-00379  C17B-00380  C17B-00419  C17A-00426  C17B-00290  C17B-00295  C17B-00296  C17B-00372  C17B-00382  C17B-00383  C17B-00390  C17A-01271  C17A-01350  C17B-00012  C17B-00018  C17B-00020  C17B-00021  C17B-00027  C17B-00028  C17B-00035  C17B-00040  C17B-00041  C17B-00042  C17A-01353  C17A-01379  C17A-01380  C17B-00022  C17B-00047  C17B-00051  C17B-00052  C17B-00053  C17B-00054  C17B-00055  C17A-01346  C17A-01348  C17A-01352  C17A-01388  C17B-00024  C17B-00066  C17B-00067  C17B-00068  C17B-00073  C17B-00075  C17B-00080  C17B-00086  C17B-00091  C17B-00212  C17B-00222  C17B-00234  C17B-00249  C17B-00250  C17B-00251  C17B-00252  C17B-00253  C17B-00273  C17B-00275  C17B-00280  C17B-00286  C17B-00297  C17B-00298  C17B-00301  C17B-00303  C17B-00304  C17B-00305  C17B-00318  C17B-00331  C17B-00342  C17B-00348  C17B-00363  C17B-00366  C17B-00370  C17A-01345  C17B-00418  C16K-00903  C17A-00831  C17A-00886  C17A-01264  C17A-01294  C17A-01298  C17B-00093  C17B-00097  C17B-00368  C17B-00381  C17B-00385  C17B-00046  C17B-00554  C17B-00217  C17B-00236  C17B-00315  C17B-00039  C17B-00180  C17B-00406  C17B-00407  C17B-00440  C17A-01151  C17A-01153  C17A-01155  C17A-01156  C17A-01157  C17A-01158  C17A-01159  C17A-01160  C17A-01212  C17A-01213  C17A-01214  C17A-01215  C17A-01216  C17A-01217  C17A-01220  C17A-01222  C17A-01223  C17A-01224  C17A-01225  C17A-01226  C17A-01228  C17A-01230  C17A-01234  C17A-01240  C17A-01273  C17A-01274  C17A-01279  C17A-01280  C17A-01291  C17A-01299  C17A-01300  C17A-01365  C17A-01369  C17A-01370  C17B-00058"
    }
  ]
}