Device Recall ROHO HIGH PROFILE Single Compartment Cushion

  • 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
    1
  • ¿Implante?
    No
  • 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
  • 1 Event

Fabricante

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