FDA Device recall Z-1549-2013

Aperio ScanScope System

FDA Device
Class II
terminated
Published 2013-06-26

On 2013-06-26 the FDA classified a Class II recall of Aperio ScanScope System by Aperio Technologies, citing 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 Res….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-1549-2013
Classification	Class II
Status	terminated
Initiated	2013-02-22
Published	2013-06-26
Last updated	2026-09-13 11:53 UTC
Company	Aperio Technologies
Distribution	US

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.

Reason

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.

Identifiers

code_info	The following serial numbers of the Aperio ScanScope systems are affected in the USA by this recall: ¿ScanScope XT… 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

code_info

The following serial numbers of the Aperio ScanScope systems are affected in the USA by this recall: ¿ScanScope XT…

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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1549-2013%22

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