Events

Retiro De Equipo (Recall) de Medcare Products Max500 Stand, Total Support

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 Products LLC DBA Prism Medical Services USA.

¿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
    66056
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0371-2014
  • Fecha de inicio del evento
    2013-10-30
  • Fecha de publicación del evento
    2013-11-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-05-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121498
  • 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
    The lift might fail with the labeled 500-lb. load rating.
  • Acción
    The firm, Medcare Products, sent an "URGENT FIELD CORRECTIVE ACTIONS" letter dated October 21, 2013 via certified mail on October 30, 2013 to its customers. The letter described the product, problem and action to be taken. The customers were instructed to peel off the boom stickers and serial number label and replace with the new ones supplied; review the revised Manual and dispose of the original; and complete the action report form once the products have been relabeled. Please refer to your Operations Manual or visit our website at www.medcarelifts.com to view the manual online. If we can answer any questions that you may have regarding the testing standards or the relabeling of the products, please do not hesitate to contact us at 1-800-695-4479.

Device

Medcare Products Max500 Stand, Total Support
  • Modelo / Serial
    Serial numbers 0106SWH0008, 0106SWH0009, 0106SWH0010, 0107SWH0031, 0107SWH0032, 0107SWH0033, 0107SWH0034, 0108SWH0044, 0108SWH0045, 0109SWH0065, 0109SWH0066, 0109SWH0067, 0109SWH0068, 0109SWH0069, 0109SWH0070,  0109SWH0071, 0111SWH0148, 0111SWH0149, 0111SWH0150,  0111SWH0151, 0112SWH0199, 0112SWH0200, 0112SWH0201, 0112SWH0202, 0112SWH0203, 0112SWH0204, 0206SWH0011, 0206SWH0012, 0209SWH0072, 0209SWH0073, 0209SWH0074, 0209SWH0075, 0209SWH0076, 0209SWH0077, 0209SWH0078, 0209SWH0079, 0211SWH0152, 0211SWH0153, 0211SWH0154, 0211SWH0155, 0211SWH0156, 0212SWH0210, 0212SWH0205, 0212SWH0206, 0212SWH0207, 0212SWH0208, 0212SWH0209, 0307SWH0035, 0308SWH0046, 0308SWH0047, 0309SWH0080, 0309SWH0081, 0309SWH0082, 0311SWH0157, 0311SWH0158, 0312SWH0211, 0312SWH0212, 0312SWH0213, 0312SWH0214, 0313SWH0234, 0313SWH0235, 0313SWH0236, 0408SWH0048, 0409SWH0083, 0409SWH0084, 0409SWH0085, 0409SWH0086, 0409SWH0087, 0409SWH0088, 0409SWH0089, 0409SWH0090, 0409SWH0091, 0409SWH0092, 0409SWH0093, 0409SWH0094, 0409SWH0095, 0409SWH0096, 0409SWH0097, 0409SWH0098, 0409SWH0099, 0411SWH0159, 0411SWH0161, 0412SWH0215,  0412SWH0216, 0507SWH0036, 0507SWH0037, 0507SWH0038, 0507SWH0039, 0508SWH0050, 0510SWH0118, 0510SWH0119, 0510SWH0120, 0510SWH0121, 0511SWH0162, 0511SWH0163, 0511SWH0164, 0512SWH0217, 0512SWH0218, 0512SWH0219, 0512SWH0220, 0512SWH0221, 0512SWH0222, 0613SWH0237, 0613SWH0238, 0613SWH0239, 0613SWH0240, 0613SWH0241, 0613SWH0242, 0613SWH0243, 0613SWH0244, 0613SWH0245, 0613SWH0246, 0613SWH0247, 0613SWH0248, 0613SWH0249, 0613SWH0250, 0708SWH0052, 0708SWH0053, 0709SWH0100, 0710SWH0122, 0710SWH0123, 0711SWH0165, 0711SWH0166, 0711SWH0167, 0711SWH0168, 0711SWH0169, 0711SWH0170, 0712SWH0223, 0712SWH0224, 0712SWH0225, 0805SWH0001, 0805SWH0002, 0805SWH0003, 0805SWH0004, 0806SWH0013, 0806SWH0014, 0806SWH0015, 0806SWH0016, 0808SWH0054, 0808SWH0055, 0808SWH0056, 0809SWH0101, 0810SWH0124, 0810SWH0125, 0810SWH0126, 0810SWH0127, 0812SWH0226, 0812SWH0227, 0812SWH0228, 0906SWH0017, 0907SWH0040, 0908SWH0057, 0908SWH0058, 0908SWH0059, 0908SWH0060,  0908SWH0061, 0908SWH0062, 0910SWH0128, 0910SWH0129, 0910SWH0130, 0910SWH0131, 0910SWH0132, 0910SWH0133, 0910SWH0134, 0910SWH0135, 0910SWH0136, 0910SWH0137, 0910SWH0138, 0910SWH0139, 0911SWH0171, 0911SWH0172, 0911SWH0173, 0911SWH0174, 0911SWH0175, 0911SWH0176, 0911SWH0177, 0911SWH0178, 0911SWH0179, 0911SWH0180, 0911SWH0181, 0911SWH0182, 0911SWH0183, 0911SWH0184, 1006SWH0018, 1006SWH0019, 1006SWH0020, 1006SWH0021, 1006SWH0022, 1006SWH0023, 1006SWH0024, 1007SWH0041, 1007SWH0042, 1007SWH0043, 1009SWH0102, 1009SWH0103, 1009SWH0104, 1009SWH0105, 1009SWH0106, 1009SWH0107,  1009SWH0108, 1009SWH0109, 1009SWH0110, 1009SWH0111,  1009SWH0112, 1009SWH0113, 1009SWH0114, 1011SWH0185, 1012SWH0229, 1012SWH0230, 1012SWH0231, 1012SWH0232, 1106SWH0025, 1106SWH0026, 1106SWH0027, 1106SWH0028, 1106SWH0029, 1106SWH0030, 1108SWH0063, 1108SWH0064, 1109SWH0115, 1110SWH0140, 1110SWH0141, 1111SWH0195, 1205SWH0005, 1205SWH0006, 1205SWH0007, 1209SWH0116, 1209SWH0117, 1210SWH0142, 1210SWH0144, 1210SWH0145, 1210SWH0146, and 1210SWH0147
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution.
  • Descripción del producto
    Medcare Products Max-500 Stand-N-Weigh, Total Support, patient stand, model #400007. The responsible firm name listed in the Operations Manual is Medcare Products, Burnsville, MN. || Used for assisting patients/residents to a standing position.
  • Manufacturer
    Ergosafe Products LLC DBA Prism Medical Services USA

Manufacturer

Ergosafe Products LLC DBA Prism Medical Services USA
  • Dirección del fabricante
    Ergosafe Products LLC DBA Prism Medical Services USA, 45 Progress Pkwy, Maryland Heights MO 63043-3701
  • Empresa matriz del fabricante (2017)
    Triona Holding Sa
  • Source
    USFDA