{
  "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": "2026-08-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "30170",
      "product_res_number": "Z-0568-04",
      "event_date_initiated": "2003-10-27",
      "event_date_posted": "2004-07-20",
      "recall_status": "Terminated",
      "event_date_terminated": "2011-12-21",
      "res_event_number": "27606",
      "product_code": "LPA",
      "pma_numbers": [
        "P840002S9"
      ],
      "product_description": "The device is labeled as AMS TAPSYSTEM Model 2A Esophageal Pulse generator (used in the Operating Room at Hospitals) and is labeled as ''MANUFACTURED FOR ARZCO MEDICAL SYSTEMS, INC. PO BOX 1048, TAMPA, FL 33601 1-800-231-6370 MODEL S/N''",
      "code_info": "THE FOLLOWING SERIAL NUMBERS ARE INVOLVED IN THE RECALL: 1031\t1073\t1120\t1162\t1210\t1256\t1296\t1348\t1401\t1475 1033\t1074\t1121\t1163\t1211\t1257\t1297\t1349\t1403\t1476 1034\t1075\t1122\t1164\t1212\t1258\t1298\t1350\t1404\t1477 1035\t1077\t1124\t1165\t1213\t1260\t1304\t1351\t1407\t1478 1037\t1078\t1127\t1168\t1214\t1261\t1305\t1354\t1408\t1480 1038\t1080\t1128\t1169\t1216\t1262\t1306\t1355\t1409\t1481 1039\t1081\t1129\t1170\t1217\t1264\t1307\t1356\t1410\t1482 1041\t1085\t1130\t1174\t1218\t1266\t1308\t1357\t1411\t1483 1042\t1086\t1131\t1177\t1220\t1267\t1309\t1360\t1412\t1485 1046\t1087\t1132\t1178\t1221\t1268\t1310\t1361\t1413\t1486 1047\t1089\t1133\t1180\t1222\t1269\t1311\t1365\t1414\t1487 1048\t1090\t1134\t1183\t1223\t1270\t1314\t1366\t1415\t1488 1049\t1091\t1136\t1184\t1224\t1271\t1319\t1372\t1416\t1489 1050\t1092\t1137\t1185\t1225\t1272\t1320\t1375\t1417\t1492 1051\t1094\t1138\t1186\t1226\t1274\t1324\t1376\t1418\t1493 1052\t1096\t1139\t1187\t1228\t1275\t1325\t1377\t1420\t1494 1053\t1098\t1140\t1188\t1229\t1276\t1326\t1378\t1421\t1495 1054\t1101\t1141\t1189\t1231\t1277\t1328\t1379\t1422\t1496 1056\t1103\t1142\t1190\t1232\t1278\t1329\t1380\t1423\t1497 1057\t1104\t1143\t1191\t1233\t1279\t1330\t1381\t1436\t1498 1058\t1105\t1144\t1192\t1234\t1280\t1331\t1382\t1444\t1499 1059\t1106\t1146\t1193\t1235\t1281\t1332\t1383\t1445\t1500 1060\t1107\t1147\t1195\t1236\t1283\t1333\t1384\t1459\t1563 1061\t1108\t1154\t1196\t1238\t1284\t1335\t1386\t1460\t1568 1063\t1109\t1155\t1197\t1242\t1285\t1337\t1388\t1462\t1569 1064\t1110\t1156\t1198\t1243\t1286\t1338\t1390\t1465\t1570 1066\t1111\t1157\t1201\t1244\t1289\t1339\t1393\t1466\t1571 1068\t1112\t1158\t1205\t1248\t1290\t1340\t1395\t1467\t1572 1069\t1114\t1159\t1206\t1250\t1291\t1341\t1396\t1472\t 1070\t1116\t1160\t1208\t1253\t1292\t1342\t1398\t1473\t 1071\t1117\t1161\t1209\t1255\t1294\t1347\t1400\t1474",
      "firm_fei_number": "1927197",
      "recalling_firm": "Cardiocommand Inc.",
      "address_1": "4920 W Cypress St Ste 110 4920 W Cypress St",
      "address_2": "Ste 110",
      "city": "Tampa",
      "state": "FL",
      "postal_code": "33607-3837",
      "additional_info_contact": "Cathy Conley\n813-289-5555",
      "reason_for_recall": "The device may exhibit spurious heart rate increase during esophageal atrial pacing during simultaneous adjacent use of electrosurgical coagulation devices.",
      "root_cause_description": "Other",
      "action": "The firm notified all user accounts and distributors by mailing a recall notifiation letter via certified first class mail on 10/31/2003 with a serial number list, photo of the device and a 'RECALL INFORMATION RETURN SHEET' for response.  A second recall letter was sent out on January 15, 2004 via certified mail to all non responding accounts. The firms were asked to return recalled units, or identify the address of accounts they were transferred to and to notify these accounts.",
      "product_quantity": "307",
      "distribution_pattern": "The devices under recall are at 142 domestic hospitals nationwide and to eight distributors in Canada, Hong Kong, the Netherlands, LA, HI, KY, AR and FL.",
      "openfda": {
        "pma_number": [
          "P840002",
          "P860008"
        ],
        "registration_number": [
          "1927197"
        ],
        "fei_number": [
          "1927197"
        ],
        "device_name": "System, Esophageal Pacing",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}