Events

Recall of ROHO MID PROFILE SINGLE COMPARTMENT CUSHION WITH SENSOR READY TECHNOLOGY

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by ROHO INC..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    77328
  • Event Risk Class
    II
  • Event Initiated Date
    2017-03-22
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    A problem was discovered internally with a supplied component for the affected products. when a smart check by roho is used to perform a smart setup with one of the affected cushions the nonconforming part may adversely affect the setup process resulting in an improper cushion setup.

Device

ROHO MID PROFILE SINGLE COMPARTMENT CUSHION WITH SENSOR READY TECHNOLOGY
  • Model / Serial
    Model Catalog: 1 R91 OM-CF-SR (Lot serial: S/N: A2920163 through A3185287); Model Catalog: 1 R91 OM-CA-SR (Lot serial: S/N: A2920163 through A3185287); Model Catalog: 1 R89M-CF-SR (Lot serial: S/N: A2920163 through A3185287); Model Catalog: 1 R89M-CA-SR (Lot serial: S/N: A2920163 through A3185287); Model Catalog: 1 R88M-CF-SR (Lot serial: S/N: A2920163 through A3185287); Model Catalog: 1 R88M-CA-SR (Lot serial: S/N: A2920163 through A3185287); Model Catalog: 1 R81 OM-CA-SR (Lot serial: S/N: A2920163 through A3185287); Model Catalog: 1 R78M-CF-SR (Lot serial: S/N: A2920163 through A3185287); Model Catalog: 1 R78M-CA-SR (Lot serial: S/N: A2920163 through A3185287); Model Catalog: 1 R77M-CF-SR (Lot serial: S/N: A2920163 through A3185287); Model Catalog: 1 R77M-CA-SR (Lot serial: S/N: A2920163 through A3185287); Model Catalog: 1 R1111 M-CH-SR (Lot serial: S/N: A2920163 through A3185287); Model Catalog: 1 R1111 M-CF-SR (Lot serial: S/N: A2920163 through A3185287); Model Catalog: 1 R1111 M-CA-SR (Lot serial: S/N:
  • Product Description
    ROHO MID PROFILE SINGLE COMPARTMENT CUSHION WITH SENSOR READY TECHNOLOGY;ROHO HIGH PROFILE SINGLE COMPARTMENT CUSHION WITH SENSOR READY TECHNOLOGY
  • Manufacturer
    ROHO INC.

Manufacturer

ROHO INC.
  • Manufacturer Address
    BELLEVILLE
  • Manufacturer Parent Company (2017)
    Investor AB
  • Source
    HC