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U.S. Department of Health and Human Services

Class 2 Device Recall Aperio ScanScope System

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  Class 2 Device Recall Aperio ScanScope System see related information
Date Initiated by Firm February 22, 2013
Date Posted June 17, 2013
Recall Status1 Terminated 3 on September 25, 2013
Recall Number Z-1549-2013
Recall Event ID 33728
Product Classification Microscope, phase contrast - Product Code IBM
Product 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.
Code Information 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  
Recalling Firm/
Manufacturer		 Aperio Technologies Inc
1360 Park Center DR
Vista CA 92081-8300
For Additional Information Contact
760-304-6211 Ext. 6211
Manufacturer Reason
for Recall		 Aperio initiated this recall because the User Guides incorrectly state the devices had been cleared for specific applications. The User Guides should state the devices are for Research Use Only and are not for use in diagnostic procedures.
FDA Determined
Cause 2		 No Marketing Application
Action Aperio sent an Urgent Medical Device Recall letter dated April 22, 2013 to all affected consignees via certified USPS mail. The letter included the reason for the recall, recall product information, instructions, acknowledgement form, contact information ( Aperio Technical Support at 1-866-478-3999), and product labeling. The consignees were requested to acknowledge receipt of the Medical Device Correction letter. In addition, an Acknowledgement Form is required to be signed and e-mailed back to the Manufacturer as evidence of letter receipt. For questions regarding this recall call 760-304-6211, ext 6211.
Quantity in Commerce 364
Distribution Nationwide Distribution - including all states, none internationally .
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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