Events

Rappel de Device Recall Aperio ScanScope System

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Aperio Technologies Inc.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    33728
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1549-2013
  • Date de mise en oeuvre de l'événement
    2013-02-22
  • Date de publication de l'événement
    2013-06-17
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-09-25
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=42354
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Microscope, phase contrast - Product Code IBM
  • Cause
    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.
  • 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.

Device

Device Recall Aperio ScanScope System
  • Modèle / numéro de série
    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
  • Classification du dispositif
    Hematology and Pathology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution - including all states, none internationally .
  • Description du dispositif
    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
    Aperio Technologies Inc

Manufacturer

Aperio Technologies Inc
  • Adresse du fabricant
    Aperio Technologies Inc, 1360 Park Center DR, Vista CA 92081-8300
  • Société-mère du fabricant (2017)
    Danaher Corporation
  • Source
    USFDA