AMS Tapsystem

THE FOLLOWING SERIAL NUMBERS ARE INVOLVED IN THE RECALL: 1031 1073 1120 1162 1210 1256 1296 1348 1401 1475 1033 1074 1121 1163 1211 1257 1297 1349 1403 1476 1034 1075 1122 1164 1212 1258 1298 1350 1404 1477 1035 1077 1124 1165 1213 1260 1304 1351 1407 1478 1037 1078 1127 1168 1214 1261 1305 1354 1408 1480 1038 1080 1128 1169 1216 1262 1306 1355 1409 1481 1039 1081 1129 1170 1217 1264 1307 1356 1410 1482 1041 1085 1130 1174 1218 1266 1308 1357 1411 1483 1042 1086 1131 1177 1220 1267 1309 1360 1412 1485 1046 1087 1132 1178 1221 1268 1310 1361 1413 1486 1047 1089 1133 1180 1222 1269 1311 1365 1414 1487 1048 1090 1134 1183 1223 1270 1314 1366 1415 1488 1049 1091 1136 1184 1224 1271 1319 1372 1416 1489 1050 1092 1137 1185 1225 1272 1320 1375 1417 1492 1051 1094 1138 1186 1226 1274 1324 1376 1418 1493 1052 1096 1139 1187 1228 1275 1325 1377 1420 1494 1053 1098 1140 1188 1229 1276 1326 1378 1421 1495 1054 1101 1141 1189 1231 1277 1328 1379 1422 1496 1056 1103 1142 1190 1232 1278 1329 1380 1423 1497 1057 1104 1143 1191 1233 1279 1330 1381 1436 1498 1058 1105 1144 1192 1234 1280 1331 1382 1444 1499 1059 1106 1146 1193 1235 1281 1332 1383 1445 1500 1060 1107 1147 1195 1236 1283 1333 1384 1459 1563 1061 1108 1154 1196 1238 1284 1335 1386 1460 1568 1063 1109 1155 1197 1242 1285 1337 1388 1462 1569 1064 1110 1156 1198 1243 1286 1338 1390 1465 1570 1066 1111 1157 1201 1244 1289 1339 1393 1466 1571 1068 1112 1158 1205 1248 1290 1340 1395 1467 1572 1069 1114 1159 1206 1250 1291 1341 1396 1472  1070 1116 1160 1208 1253 1292 1342 1398 1473  1071 1117 1161 1209 1255 1294 1347 1400 1474

Cardiovascular Devices

3

No

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.

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''