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U.S. Department of Health and Human Services

Class 2 Device Recall Smith & Nephew 560P High Definition Camera Control Unit

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 Class 2 Recall
Smith & Nephew 560P High Definition Camera Control Unit
see related information
Date Posted May 01, 2012
Recall Status1 Open
Recall Number Z-1479-2012
Recall Event ID 61604
Premarket Notification
510(K) Number
K070266 
Product Classification Laparoscope, General & Plastic Surgery - Product Code GCJ
Product Smith & Nephew 560P High Definition Camera Control Unit Catalog Number: 72201919 The 560P camera system is configured to be connected as a stand-alone system on an endoscopic cart or tower. It is designed for use with the Smith & Nephew 560H 3-CCD High Definition Camera Head (560H camera head). The 560P camera system is designed to be used in conjunction with various peripheral devices, including the 560H camera head, Smith & Nephews 300 watt xenon light source, various flat panel displays, image capture devices, and print and video recording devices.
Code Information Serial Numbers: BBS0835 BBS0869 BBS0973 BBS1096 BBS1100 BBS1103 BBS1105 BBS1106 BBS1109 BBS1114 BBS1115 BBS1120 BBS1124 BBS1125 BBS1133 BBS1135 BBS1138 BBS1139 BBS1140 BBS1141 BBS1142 BBS1143 BBS1144 BBS1151 BBS1153 BBS1158 BBS1178 BBS1187 BBS1190 BBS1191 BBS1192 BBS1194 BBS1198 BBS1202 BBS1203 BBS1206 BBS1214 BBS1218 BBS1223 BBS1230 BBS1232 BBS1236 BBS1237 BBS1239 BBS1240 BBS1241 BBS1242 BBS1243 BBS1245 BBS1246 BBS1247 BBS1248 BBS1249 BBS1250 BBS1251 BBS1252 BBS1253 BBS1254 BBS1255 BBS1256 BBS1258 BBS1259 BBS1261 BBS1262 BBS1265 BBS1267 BBS1268 BBS1269 BBS1270 BBS1271 BBS1273 BBS1275 BBS1277 BBS1278 BBS1280 BBS1281 BBS1284 BBS1285 BBS1299 BBS1303 BBS1304 BBS1305 BBS1306 BBS1307 BBS1308 BBS1310 BBS1311 BBS1314 BBS1316 BBS1321 BBS1322 BBS1323 BBS1324 BBS1325 BBS1326 BBS1329 BBS1330 BBS1334 BBS1335 BBS1336 BBS1345 BBS1348 BBS1349 BBS1351 BBS1352 BBS1354 BBS1355 BBS1356 BBS1357 BBS1358 BBS1359 BBS1360 BBS1364 BBS1370 BBS1371 BBS1372 BBS1373 BBS1374 BBS1375 BBS1376 BBS1377 BBS1378 BBS1380 BBS1381 BBS1382 BBS1383 BBS1385 BBS1386 BBS1388 BBS1389 BBS1390 BBS1391 BBS1396 BBS1398 BBS1399 BBS1401 BBS1402 BBS1403 BBS1404 BBS1405 BBS1408 BBS1410 BBS1411 BBS1412 BBS1414 BBS1416 BBS1417 BBS1418 BBS1419 BBS1420 BBS1421 BBS1422 BBS1423 BBS1424 BBS1426 BBS1427 BBS1429 BBS1430 BBS1432 BBS1433 BBS1434 BBS1436 BBS1439 BBS1440 BBS1441 BBS1442 BBS1443 BBS1445 BBS1447 BBS1450 BBS1451 BBS1452 BBS1453 BBS1455 BBS1456 BBS1457 BBS1458 BBS1459 BBS1460 BBS1462 BBS1464 BBS1465 BBS1466 BBS1468 BBS1469 BBS1471 BBS1472 BBS1473 BBS1474 BBS1475 BBS1476 BBS1477 BBS1479 BBS1480 BBS1481 BBS1482 BBS1483 BBS1484 BBS1485 BBS1487 BBS1488 BBS1490 BBS1491 BBS1492 BBS1493 BBS1494 BBS1495 BBS1496 BBS1497 BBS1498 BBS1499 BBS1500 BBS1501 BBS1502 BBS1503 BBS1504 BBS1505 BBS1506 BBS1508 BBS1509 BBS1515 BBS1519 BBS1531 BBS1533 BBS1537 BBS1538 BBS1539 BBS1548 BBS1567 BBS1571 BBS1591 BBS1592 BBS1657 BBS1658 BBS1671 BBS1673 BBS1697 BBS1724 BBS2133
Recalling Firm/
Manufacturer
Smith & Nephew, Inc. Endoscopy Division
150 Minuteman Drive
Andover, Massachusetts 01810-1031
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
May experience intermittent loss of video due to a defective board component
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action Smith & Nephew Endoscopy Division sent an "URGENT PRODUCT RECALL 1st NOTIFICATION" letter to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. The letter instructs customers to check their inventory and to complete and return the bottom portion of the letter via fax at 405-917-8650. Contact the firm at 405-917-8556 for questions regarding this notice.
Quantity in Commerce 239 units
Distribution Worldwide Distribution-USA (nationwide) and the countries of Austria, Belgium, Canada, Denmark, Finland, France, Germany, Italy, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, and UK Asia-pacific: Australia, China, Hong Kong, India, Japan, Singapore, South Korea, and Thailand, Mexico, Puerto Rico, South Africa, Turkey, and Venezuela.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = GCJ and Original Applicant = SMITH & NEPHEW, INC.
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