Device Recall Aperio ScanScope System

  • Model / Serial
    The following serial numbers of the Aperio ScanScope systems are affected in the USA by this recall:  ¿ScanScope XT ScanScope AT ScanScope ATT ScanScope es, esa  1223, 1273, 1278, 1277, 1282, 1593,1605, 1648,1657,1660, 5064,5068,5108,5155,5170,5171  1285,1286,1287,1293,1296, 1619, 1620, 1662,1663,1666, 5176,5181,5187,5196,5198,5202,  1299,1300,1301,1302,1304, 1623, 1633, 1671, 1672, 1673, 5204,5205,5233,5236,5237,5241,  1311,1312,1314,1315,1316, 1634,1635, 1676, 1678, 1679, 5244,5245,5246,5248,5253,5262,  1318,1319,1320,1321,1322, 1636, 1637, 1690, 1692, 1695, 5266,5267,5269,5270,5272,5276,  1324,1325,1327,1328,1330, 1638,1640, 1698,1700,1718 5277,5279,5283,5287,5288,5293,  1332, 1333, 1335, 1336, 1338, 1643,1645, 5294, 5295, 5302, 5307, 5308, 5309,  1339, 1340, 1342, 1343, 1345, 1649,1654, 5314,5315,5316,5317,5324,5327,  1350,1352,1357,1358,1359, 1656,1664, 5328,5329,5330,5331,5333,5334,  1366, 1368, 1369, 1370, 1372, 1686, 1687, 5336,5339,5340,5341,5345,5347,  1382,1383,1392,1394,1396, 1688, 1689, 5348,5352,5353,5356,5367,5371,  1397, 1399, 1400, 1402, 1404, 1696, 1699, 5374,5379,5381,5388,5390,5394,  1405,1407,1409,1410,1413, 1703,1705, 5396,5402,5403,5404,5405,5406,  1417,1418,1419,1420,1421, 1707, 1708, 5408,5409,5415,5416,5418,5419,  1422, 1423, 1424, 1425, 1426, 1709,1711, 5433,5440,5452,5456,5457,5459,  1436,1441,1442,1444,1445, 1714,1716, 5462,5465,5466,5467,5468,5469,  1446, 1448, 1449, 1450, 1452, 1719,1721, 5470,5473,5475,5476,5477,5478,  1453, 1454, 1456, 1457, 1458, 1723,1724, 5482,5485,5486,5489,5490,5492,  1460,1461,1466,1475,1476, 1725,1727, 5493,5504,5515,5516,5517,5518,  1481,1482,1486,1487,1490, 1728,1729, 5520, 5529, 5537, 5540, 5552, 5566,  1492, 1499, 1500, 1502, 1503, 1731,1733, 5567,5574,5578,5581,5587,5590,  1505,1506,1507,1508,1509, 1735, 1736, 5591,5592,5593  1511,1512,1514,1515,1516, 1739,1744  1517,1519,1520,1522,1523,  1525, 1527, 1528, 1532, 1534,  1535, 1536, 1537, 1538, 1540,  1542,1543,1544,1545,1546,  1547,1548,1549,1550,1551,  1552, 1553, 1554, 1556, 1557,  1559,1560,1563,1564,1569,  1570, 1571, 1575, 1576, 1582,  1586,1587,1588,1590,1591,  1596,1597,1611,1627
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution - including all states, none internationally .
  • Product Description
    Aperio ScanScope System. Aperio ScanScope Models, XT, AT, AT Turbo, CS and CSO. || Automated digital slide creation and viewing device. || It is intended to create and view electronic image files representative of tissue specimens fixed to glass slides.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Aperio Technologies Inc, 1360 Park Center DR, Vista CA 92081-8300
  • Manufacturer Parent Company (2017)
  • Source
    USFDA