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U.S. Department of Health and Human Services

Class 2 Device Recall ROHO HIGH PROFILE Single Compartment Cushion

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  Class 2 Device Recall ROHO HIGH PROFILE Single Compartment Cushion see related information
Date Initiated by Firm March 20, 2017
Date Posted April 05, 2017
Recall Status1 Terminated 3 on May 10, 2019
Recall Number Z-1921-2017
Recall Event ID 76836
Product Classification Cushion, flotation - Product Code KIC
Product ROHO HIGH PROFILE Single Compartment Cushion with Sensor Ready Technology and ROHO MID PROFILE Single Compartment Cushion with Sensor Ready Technology.
Code Information Serial Numbers: A2920163 through A3185287 Model Numbers: 1R1010H-CA-SC, 1R109M-CA-SR, 1R1211H-CH-SR, 1R88H-CA-SR, 1R1010H-CA-SCDM, 1R109M-CF-SR, 1R1212H-CA-SR, 1R88H-CF-SR, 1R1010H-CA-SR, 1R109M-CH-SR, 1R1212H-CH-SR, 1R88H-CH-SR, 1R1010H-CF-SCDM, 1R1110H-CA-SC, 1R129H-CA-SR, 1R88M-CA-SR, 1R1010H-CF-SR, 1R1110H-CA-SR, 1R1310H-CA-SR, 1R88M-CF-SR, 1R1010H-CH-SR, 1R1110H-CF-SR, 1R1310H-CF-SR, 1R89H-CA-SR, 1R1010M-CA-SC, 1R1110H-CH-SC, 1R1311H-CA-SR, 1R89H-CF-SR, 1R1010M-CA-SCDM, 1R1110H-CH-SR, 1R1311H-CH-SR, 1R89M-CA-SR, 1R1010M-CA-SR, 1R1110M-CA-SR, 1R1411H-CA-SR, 1R89M-CF-SR, 1R1010M-CF-SCDM, 1R1110M-CF-SR, 1R1411H-CF-SR, 1R910H-CA-SR, 1R1010M-CF-SR, 1R1110M-CH-SC, 1R1511H-CA-SR, 1R910H-CF-SR, 1R1010M-CH-SR, 1R1110M-CH-SR, 1R66H-CA-SR, 1R910H-CH-SC, 1R1011H-CA-SC, 1R1111H-CA-SC, 1R66H-CF-SR, 1R910H-CH-SR, 1R1011H-CA-SR, 1R1111H-CA-SR, 1R67H-CF-SR, 1R910M-CA-SR, 1R1011H-CF-SR, 1R1111H-CF-SR, 1R77H-CA-SR, 1R910M-CF-SR, 1R1011H-CH-SC, 1R1111H-CH-SC, 1R77H-CF-SR, 1R911H-CA-SC, 1R1011H-CH-SR, 1R1111H-CH-SR, 1R77M-CA-SR, 1R911H-CA-SR, 1R1011M-CA-SC, 1R1111M-CA-SR, 1R77M-CF-SR, 1R911H-CF-SR, 1R1011M-CA-SR, 1R1111M-CF-SR, 1R78H-CA-SR, 1R911H-CH-SR, 1R1011M-CF-SR, 1R1111M-CH-SR, 1R78H-CF-SR, 1R98H-CA-SR, 1R1012H-CA-SR, 1R1112H-CA-SR, 1R78M-CA-SR, 1R98H-CF-SR, 1R1012H-CF-SR, 1R1112H-CF-SR, 1R78M-CF-SR, 1R99H-CA-SC, 1R1012H-CH-SR, 1R1112H-CH-SR, 1R79H-CA-SR, 1R99H-CA-SCDM, 1R108H-CA-SR, 1R119H-CA-SC, 1R79H-CF-SR, 1R99H-CA-SR, 1R108H-CF-SR, 1R119H-CA-SR, 1R810H-CA-SR, 1R99H-CF-SCDM, 1R109H-CA-SCDM, 1R119H-CF-SR, 1R810H-CF-SR, 1R99H-CF-SR, 1R109H-CA-SR, 1R1210H-CA-SC, 1R810M-CA-SR, 1R99H-CH-SR, 1R109H-CF-SCDM, 1R1210H-CA-SR, 1R87H-CA-SC, 1R99M-CA-SR, 1R109H-CF-SR, 1R1210H-CF-SR, 1R87H-CA-SR, 1R99M-CF-SR, 1R109H-CH-SC, 1R1210H-CH-SR, 1R87H-CF-SR, 1R99M-CH-SR, 1R109H-CH-SR, 1R1211H-CA-SR
Recalling Firm/
Manufacturer		 Roho Inc.
100 N Florida Ave
Belleville IL 62221-5429
For Additional Information Contact ROHO, Inc. Warranty Service Department
800-851-3449
Manufacturer 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.
FDA Determined
Cause 2		 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 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.
Quantity in Commerce 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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