Events

Retiro De Equipo (Recall) de Device Recall Medcare Lift with Scale Medcare Lift w/Scale 600 lb Scale Hanger Assembly

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por ErgoSafe Product LLC dba Prism Medical Services.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    67804
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1450-2014
  • Fecha de inicio del evento
    2013-05-10
  • Fecha de publicación del evento
    2014-04-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-11-20
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126363
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Lift, patient, non-ac-powered - Product Code FSA
  • Causa
    Medcare products has determined that a number of their floor lifts manufactured from 9/1/2010 to 11/7/2012 do not meet medcare's high standards. the original design includes a pin that over time and years of use may stop performing as designed and may break.
  • Acción
    Medcare sent a Notification letter dated May 10th, 2013 to affected customers. The letter described the affected product, problem, actions to be taken and provided a replacement assembly. It instructed consignees to replace the old assembly with the new one included in the package. For questions they can contact Todd Perrine in their Technical Support Department at 952-300-2101.

Device

Device Recall Medcare Lift with Scale Medcare Lift w/Scale 600 lb Scale Hanger Assembly
  • Modelo / Serial
    Serial # 0810LS1522  0810LS1523  0910LS1524  0910LS1525  0910LS1526  0910LS1527  0910LS1528  0804LS0854  0910LS1529  0910LS1530  1010LS1532  0910LS1531  1010LS1533  1010LS1534  1010LS1535  1010LS1536  1010LS1537  1010LS1538  1010LS1539  1010LS1540  1010LS1541  1010LS1542  1010LS1543  1010LS1544  1010LS1545  1010LS1546  1010LS1547  1010LS1548  1110LS1549  1201LS1551  1210LS1550  1210LS1552  1210LS1553  1210LS1554  1210LS1555  1210LS1556  1210LS1557  0111LS1558  0111LS1561  0111LS1560  0111LS1562  0111LS1563  0111LS1564  0111LS1565  0111LS1566  0111LS1567  0111LS1559  0111LS51559  0111LS1568  0211LS1569  0211LS1570  0211LS1571  0211LS1572  0311LS1573  0311LS1575  0311LS1576  0311LS1578  0311LS1577  0311LS1579  0311LS1580  0311LS1583  0311LS1581  0311LS1582  0311LS1586  0311LS1574  0311LS1585  0311LS1587  0411LS1588  0411LS1589  0411LS1590  0411LS1591  0411LS1592  0411LS1593  0411LS1594  0511LS1597  0511LS1598  0511LS1599  0511LS1596  0511LS1600  0511LS1601  0511LS1602  0411LS1595  0511LS1603  0611LS1605  0611LS1604  0611LS1606  0611LS1607  0611LS1608  0611LS1609  0611LS1610  0611LS1611  0711LS1612  0711LS1613  0711LS1614  0711LS1615  0711LS1616  0711LS1617  0711LS1618  0711LS1619  0711LS1620  0311LS1584  0711LS1621  0711LS1622  0711LS1623  0811LS1624  0711LS1625  0811LS1625  0811LS1626  0811LS1627  0811LS1628  0811LS1629  0811LS1631  0811LS1630  0911LS1632  0911LS1633  0911LS1639  0911LS1636  0911LS1641  0911LS1642  0911LS1643  0911LS1644  0911LS1634  0911LS1637  0911LS1638  0911LS1640  0911LS1645  1011LS1647  1011LS1646  1011LS1648  1011LS1649  1011LS1650  1011LS1651  1011LS1652  1011LS1653  1011LS1655  1011LS1654  1011LS1656  1011LS1658  1011LS1657  1011LS1659  1011LS1660  1211LS1661  1211LS1662  1211LS1663  1211LS1664  1211LS1665  1211LS1666  1211LS1667  1211LS1668  1211LS1669  1211LS1670  1211LS1671  1211LS1672  1211LS1673  1211LS1674  1211LS1678  0112LS1683  0112LS1681  0112LS1682  0112LS1684  1211LS1675  1211LS1676  1211LS1677  0112LS1680  0112LS1685  0911LS1635  1211LS1679  0112LS1686  0112LS1687  0112LS1688  0112LS1689  0112LS1690  0112LS1691  0212LS1693  0212LS1694  0212LS1692  0212LS1697  0212LS1698  0212LS1699  0212LS1700  0212LS1701  0212LS1702  0312LS1703  0312LS1704  0312LS1705  0412LS1706  0412LS1707  0412LS1708  0412LS1709  0412LS1710  0412LS1711  0412LS1712  0412LS1713  0412LS1714  0412LS1715  0412LS1716  0412LS1718  0412LS1720  0412LS1721  0412LS1722  0412LS1723  0412LS1724  0412LS1725  0412LS1719  0412LS1717  0412LS1727  0412LS1728  0212LS1695  0212LS1696  0412LS1729  0412LS1730  0412LS1731  0412LS1733  0412LS1734  0412LS1735  0412LS1736  0612LS1737  0612LS1738  0612LS1739  0612LS1740  0412LS1726  0412LS1732  0612LS1741  0612LS1743  0612LS1745  0612LS1746  0712LS1747  0712LS1748  0712LS1749  0712LS1750  0612LS1742  0712LS1751  0812LS1757  0712LS1752  0812LS1753   Serial #  0610FS0633  0610FS0632  0610FS0634  0910FS0635  0910FS0636  0910FS0637  0910FS0638  0910FS0639  0910FS0640  0910FS0641  1010FS0643  1010FS0644  1010FS0645  1010FS0646  1010FS0647  1010FS0648  1010FS0649  1010FS0650  1010FS0651  1010FS0652  1010FS0653  1010FS0654  1110FS0653  1110FS655  1110FS0656  1210FS0657  1210FS0658  1210FS0659  0111FS0662  0111FS0661  0111FS0663  0111FS0664  0111FS0665  0111FS0666  0111FS0660  0310FS0624  1008FS0557  0211FS0668  0211FS0669  0211FS0670  0311FS0671  0311FS0672  0311FS0673  0211FS0667  0311FS0674  0311FS0675  0411FS0676  0411FS0677  0411FS0678  0411FS0679  0511FS0681  0511FS0682  0511FS0683  0511FS0680  0611FS0684  0611FS0687  0611FS0685  0711FS0688  0711FS0690  0611FS0686  0811FS0691  0811FS0693  0811FS0695  0911FS0697  0911FS0698  0911FS0699  0811FS0692  0911FS0696  0911FS0701  0911FS0700  0911FS0702  0911FS0703  0911FS0704  0811FS0694  0911FS0705  0911FS0707  0911FS0706  0911FS0708  1011FS0711  1011FS0712  1011FS0710  0911FS0709  0112FS0722  0112FS0723  1011FS0713  1011FS0714  1011FS0715  1011FS0716  1011FS0717  1011FS0718  1011FS0719  0112FS0724  0112FS0725  0112FS0726  0212FS0733  0212FS0727  0212FS0728  0212FS0729  0212FS0730  0212FS0731  0212FS0732  0711FS0689  0212FS0734  0212FS0735  0212FS0736  0212FS0737  0412FS0741  0412FS0744  0412FS0745  0412FS0746  0412FS0739  0412FS0740  0412FS0742  0412FS0743  0512FS0747  0512FS0748  0512FS0750  0512FS0751  0512FS0749  0412FS0738  0512FS0752  0512FS0753  0512FS0754  0512FS0755  0512FS0756  0612FS0757  0612FS0758  0612FS0759  0712FS0760  0712FS0762  0712FS0763  0812FS0766  0812FS0765  0912FS0767  0912FS0768  0912FS0769  0912FS0770  0712FS0761  1012FS0777  1012FS0775  1012FS0774  0712FS0764  0912FS0771    Serial # J811784  J811850  J857892  L2A023201  L2A023217  W28213  J811920  J857848  J857885  L2A030559  5811761  5811812  L2A029637  L2A029648  L2A029630  L2A029612  L2A030550  L2A029651  L2A023200  L2A029581  L2A023207  L2A029632  L2A029635  L2A023178  L2A023173  L2A029621  L2A023248  L2A029627  L2A029611  L2A029607  L2A029601  L2A030543  L2A029629  L2A029610  L2A023238  L2A030557  21120381  21120366  21120395  21120377  21120392  21120361  21120372  L2A029614  21120400  21120401  L2A029579  J811815  L2A023216  L2A029639  L2A029626  21130612  21134922  21130598  21153516  21153542  21120397  21163412  21163415  21163425  21163432  21163409  21163416  21163404  21173082  21163400  21134899  21173085  21153494  21163438  21173109  21189283  21189286  21134911  21134897  21163408  21153554  21153560  21153520  21134907  21134916  21153512  21189284  21189293  21153481  21153530  21173080  21226274  21226285  21153479  21153524  21226278  21226275  21233710  21153511  21173075  21153548  21153508  21134903  21134920  21233715  21134910  21233717  21233723  21226273  21134917
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    USA Nationwide Distribution in the states of: CA, CO, IL, IN, IA, KS, KY, LA, ME, MD, MI, MN, MS, NO, NE,NH,NY, ND,OH, OK, OR, PA , SD, TX, WI.
  • Descripción del producto
    400003 Medcare Lift with Scale || 400013 Medcare Lift w/Scale 600 lb || 400600 Scale Hanger Assembly || Product Usage: The intended use is a patient hanger bar (400600) attached to a 400003 or 400013 floor lift used to lift, transfer or position clients.
  • Manufacturer
    ErgoSafe Product LLC dba Prism Medical Services

Manufacturer

ErgoSafe Product LLC dba Prism Medical Services
  • Dirección del fabricante
    ErgoSafe Product LLC dba Prism Medical Services, 480 University Avenue, Suite 510, Toronto, ON Canada M5GiV2
  • Empresa matriz del fabricante (2017)
    Triona Holding Sa
  • Source
    USFDA