Roho Inc. recalls ROHO HIGH PROFILE Single Compartment Cushion with Sensor Ready Technology and ROHO MID PROFILE Single Compartment Cushi…

Recall date

March 20, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1921-2017

FDA classification

Class II

Brand / firm

Roho Inc.

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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