ROHO HIGH PROFILE Single Compartment Cushion with Sensor Ready Technology and ROHO MID PROFILE Single Compartment Cushion with Sensor Ready Technology.
FDA Recall Z-1921-2017 · Posted 2017-04-05
Recalling FirmRoho Inc.
Recall StatusTerminated
Product CodeKIC
Date Initiated2017-03-20
Date Terminated2019-05-10
Product Quantity5646 units
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.
Firm 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.
Root Cause
Equipment maintenance
Distribution Pattern
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
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.