Retiro De Equipo (Recall) de Device Recall ROHO HIGH PROFILE Single Compartment Cushion

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 Roho 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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
    Open, Classified
  • País del evento
  • Fuente del evento
  • 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
    Cushion, flotation - Product Code KIC
  • Causa
    When the smart check tool is used to perform a smart setup with one of the affected cushions, it may adversely affect the setup process resulting in an improper cushion setup. sitting on an over inflated or under inflated sensor ready cushion may reduce or eliminate the benefits provided by the cushion, increasing the risk to skin or to other soft tissue.
  • Acción
    On 3/13/17, firm began notifying customers of recall via emailed or mailed letter. The notification sent to dealers and distributors includes a request to forward the communication to their customer and send an acknowledgement back once all of their customers have received a copy of the communication. Customers (product users) will not be required to send the product they are using back. Instead, the recall letter provided two options: 1) keep the cushion and follow additional set-up instructions provided within the letter that would mitigate the risk or 2) contact the supplier to have the cushion replaced. Product that had been in use and is replaced will be destroyed (evidence to be provided to ROHO, Inc. if destroyed by a customer). Unused product that is still in stock with the firm will be destroyed.


  • Modelo / Serial
    Serial Numbers: A2920163 through A3185287 Model Numbers: 1R1010H-CA-SC, 1R109M-CA-SR, 1R1211H-CH-SR, 1R88H-CA-SR, 1R1010H-CA-SCDM, 1R109M-CF-SR, 1R1212H-CA-SR, 1R88H-CF-SR, 1R1010H-CA-SR, 1R109M-CH-SR, 1R1212H-CH-SR, 1R88H-CH-SR, 1R1010H-CF-SCDM, 1R1110H-CA-SC, 1R129H-CA-SR, 1R88M-CA-SR, 1R1010H-CF-SR, 1R1110H-CA-SR, 1R1310H-CA-SR, 1R88M-CF-SR, 1R1010H-CH-SR, 1R1110H-CF-SR, 1R1310H-CF-SR, 1R89H-CA-SR, 1R1010M-CA-SC, 1R1110H-CH-SC, 1R1311H-CA-SR, 1R89H-CF-SR, 1R1010M-CA-SCDM, 1R1110H-CH-SR, 1R1311H-CH-SR, 1R89M-CA-SR, 1R1010M-CA-SR, 1R1110M-CA-SR, 1R1411H-CA-SR, 1R89M-CF-SR, 1R1010M-CF-SCDM, 1R1110M-CF-SR, 1R1411H-CF-SR, 1R910H-CA-SR, 1R1010M-CF-SR, 1R1110M-CH-SC, 1R1511H-CA-SR, 1R910H-CF-SR, 1R1010M-CH-SR, 1R1110M-CH-SR, 1R66H-CA-SR, 1R910H-CH-SC, 1R1011H-CA-SC, 1R1111H-CA-SC, 1R66H-CF-SR, 1R910H-CH-SR, 1R1011H-CA-SR, 1R1111H-CA-SR, 1R67H-CF-SR, 1R910M-CA-SR, 1R1011H-CF-SR, 1R1111H-CF-SR, 1R77H-CA-SR, 1R910M-CF-SR, 1R1011H-CH-SC, 1R1111H-CH-SC, 1R77H-CF-SR, 1R911H-CA-SC, 1R1011H-CH-SR, 1R1111H-CH-SR, 1R77M-CA-SR, 1R911H-CA-SR, 1R1011M-CA-SC, 1R1111M-CA-SR, 1R77M-CF-SR, 1R911H-CF-SR, 1R1011M-CA-SR, 1R1111M-CF-SR, 1R78H-CA-SR, 1R911H-CH-SR, 1R1011M-CF-SR, 1R1111M-CH-SR, 1R78H-CF-SR, 1R98H-CA-SR, 1R1012H-CA-SR, 1R1112H-CA-SR, 1R78M-CA-SR, 1R98H-CF-SR, 1R1012H-CF-SR, 1R1112H-CF-SR, 1R78M-CF-SR, 1R99H-CA-SC, 1R1012H-CH-SR, 1R1112H-CH-SR, 1R79H-CA-SR, 1R99H-CA-SCDM, 1R108H-CA-SR, 1R119H-CA-SC, 1R79H-CF-SR, 1R99H-CA-SR, 1R108H-CF-SR, 1R119H-CA-SR, 1R810H-CA-SR, 1R99H-CF-SCDM, 1R109H-CA-SCDM, 1R119H-CF-SR, 1R810H-CF-SR, 1R99H-CF-SR, 1R109H-CA-SR, 1R1210H-CA-SC, 1R810M-CA-SR, 1R99H-CH-SR, 1R109H-CF-SCDM, 1R1210H-CA-SR, 1R87H-CA-SC, 1R99M-CA-SR, 1R109H-CF-SR, 1R1210H-CF-SR, 1R87H-CA-SR, 1R99M-CF-SR, 1R109H-CH-SC, 1R1210H-CH-SR, 1R87H-CF-SR, 1R99M-CH-SR, 1R109H-CH-SR, 1R1211H-CA-SR
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Nationwide, Sweden, Germany, New Zealand, Finland, Australia, Singapore, Korea, Luxembourg, Czech Republic, South Africa, Canada, Switzerland, United Arab Emirates, Spain, Austria, Hong Kong, Iceland, Japan, Canada, Italy, Ireland, France, United Kingdom
  • Descripción del producto
    ROHO HIGH PROFILE Single Compartment Cushion with Sensor Ready Technology and ROHO MID PROFILE Single Compartment Cushion with Sensor Ready Technology.
  • Manufacturer


  • Dirección del fabricante
    Roho Inc., 100 N Florida Ave, Belleville IL 62221-5429
  • Empresa matriz del fabricante (2017)
  • Source