Recall Z-1921-2017— Roho Inc.
Class II · Terminated
Class II FDA medical device recall by Roho Inc., initiated 2017-03-20, terminated 2019-05-10. FDA's recall record names no specific 510(k) clearance for this event. Product: 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..
- Recalling firm
- Roho Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-03-20
- Terminated
- 2019-05-10
- Firm location
- Belleville, IL, United States
Product description
ROHO HIGH PROFILE Single Compartment Cushion with Sensor Ready Technology and ROHO MID PROFILE Single Compartment Cushion with Sensor Ready Technology.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.