Z-1549-2013Class II

Aperio ScanScope System. Aperio ScanScope Models, XT, AT, AT Turbo, CS and CSO. Automated digital slide...

Name: Z-1549-2013 Aperio ScanScope System. Aperio ScanScope Models, XT, AT, AT Turbo, CS and CSO. Automated digital slide...
Creator: Aperio Technologies Inc
Published: 2013-02-22
License: https://open.fda.gov/license/

Leica Biosystems Imaging, Inc. / initiated 2013-02-22 / Terminated

FDA source

Aperio Technologies Inc began a recall of 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... on 2013-02-22. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1549-2013
Classification: Class II
Status: Terminated
Initiated: 2013-02-22
Posted: 2013-06-17
Terminated: 2013-09-25
Recalling firm: Leica Biosystems Imaging, Inc.
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.
Product code: IBM Microscope, Phase Contrast
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 root cause: 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 .
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1549-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1549-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-26	2013-06-17

Product code IBM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)