BEUDAMED
    FDA Recall Terminated

    ROHO HIGH PROFILE Single Compartment Cushion with Sensor Ready Technology and ROHO MID PROFILE Single Compartment Cushion with Sensor Ready Technology.

    Recall: Z-1921-2017 · Initiated March 20, 2017

    Recall

    Recall Number
    Z-1921-2017
    Event Number
    76836
    Firm
    Roho Inc.
    FEI Number
    3008630266
    Product Code
    KIC
    Status
    Terminated
    Root Cause
    Equipment maintenance
    Initiated
    March 20, 2017
    Posted
    April 5, 2017
    Terminated
    May 10, 2019
    Address
    100 N Florida Ave, Belleville, IL, 62221-5429

    Description

    ROHO HIGH PROFILE Single Compartment Cushion with Sensor Ready Technology and ROHO MID PROFILE Single Compartment Cushion with Sensor Ready Technology.

    Reason

    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.

    Action

    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.

    Distribution

    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

    Quantity

    5646 units