Retiro De Equipo (Recall) de Device Recall Sechrist Low Profile Wheeled Stretcher

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 Sechrist Industries Inc.

¿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
    71455
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1939-2015
  • Fecha de inicio del evento
    2015-06-01
  • Fecha de publicación del evento
    2015-07-01
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2015-10-20
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
  • 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
    Stretcher, wheeled - Product Code FPO
  • Causa
    Sechrist industries is recalling the sechrist low profile wheeled stretcher because it may experience an unexpected incline angle during the height adjustment of the low profile wheeled stretcher when lifting the patient upward or when lowering the wheeled stretcher to a height at which the patient can be loaded/unloaded.
  • Acción
    Seachrist sent an Urgent: Medical Device Correction letter dated June 1. 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Our records indicate the Sechrist Low Profile Wheeled Stretcher identified in the attached serial number list (Attachment A) are affected by the field correction and are located at your facility. Within the following weeks, a Sechrist trained Field Service Technician will schedule a visit to your facility to install a Hydraulic Wheeled Stretcher Alignment kit which will greatly minimize the degree of the incline angle that can be experienced after it is installed. Customers are informed that within the following weeks, a Sechrist trained Field Service Technician will schedule a visit to their facility to install a Hydraulic Wheeled Stretcher Alignment kit which will greatly minimize the degree of the incline angle that can be experienced after it is installed. For further questions, please call: (714) 579-8318, or (714) 579-8311. We apologize for any disruption that this correction may cause. Sechrist is dedicated to ensuring the safety and quality of our products. If you have any questions about what to do, please contact us.

Device

  • Modelo / Serial
    Lot Code: 0086 0088 0024 0054 0056 0031 0040 0085 0046 0051 0121 0042 0032 0036 0021 0022 0015 0020 0065 0074 0066 0069 0007 0017 0005 0018 0004 0008 0062 0063 0038 0043 0033 0035 0037 0058 0071 0010 0011 0019 0049 0050 0055 0023 0039 0045 0059 0064 0028 0041 0044 0025 0001 0014 0068 0073 0057 0060 0027 0029 0030 0082 0083 0048 0070 0072 0034 0047 0009 0013 0080 0002 0081 0090 0091   Item No. 21762-135-33HJ 21762-135-33HJ 21762-135-33HJ 21762-135-33HJ 21762-135-33HJ 21762-110-36H
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Distribution and Internationally to Japan and Jordan.
  • Descripción del producto
    Sechrist Low Profile Wheeled Stretcher, Model No. 21762-110-33H, 21762-110-36H, 21762-110-41H, 21762-135-33HJ, 21762-010-36H, 21762-010-41H, || 21762-111-36H.
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    Sechrist Industries Inc, 4225 E La Palma Ave, Anaheim CA 92807-1815
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA