Recall of Device Recall ROHO HIGH PROFILE Single Compartment Cushion

Recall

76836

Class 2

Z-1921-2017

2017-03-20

2017-04-05

Open, Classified

United States

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154368

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.

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.