Recall Z-1921-2017 ยท KIC Cushion, Flotation
Roho Inc.
ROHO HIGH PROFILE Single Compartment Cushion with Sensor Ready Technology and ROHO MID PROFILE Single Compartment Cushion with Sensor Ready Technology.
| Date | Apr 5, 2017 (initiated Mar 20, 2017) |
| Status | Terminated |
| 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. |
| Root cause | Equipment maintenance |
| 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 c |
| Quantity | 5646 units |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.