ROHO HIGH PROFILE Single Compartment Cushion with recall
ROHO HIGH PROFILE Single Compartment Cushion with Sensor Ready Technology and ROHO MID PROFILE Single Compartment Cushion with Sensor Ready…
Why was ROHO HIGH PROFILE Single Compartment Cushion with 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- ROHO HIGH PROFILE Single Compartment Cushion with Sensor Ready Technology and ROHO MID PROFILE Single Compartment Cushion with Sensor Ready…
- Recalling firm
- Roho Inc.
- 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
- Recall date
- May 10, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)