The Recall Desk
HighFDA (Devices)·Z-1921-2017·Announced 2017-05-10

Roho Sensor Ready Cushions Recalled for Improper Setup Risk

Roho Inc. is recalling 5,646 units of ROHO High and Mid Profile cushions because the Smart Check tool may cause improper inflation, increasing the risk of skin or soft tissue injury.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk of harm to skin or soft tissue due to improper cushion setup. While the agency classification is Class II, the source text does not report any hospitalizations or significant injuries, fitting the criteria for a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Roho Inc. is recalling 5,646 units of ROHO High Profile and ROHO Mid Profile Single Compartment Cushions with Sensor Ready Technology. The recall covers specific serial numbers ranging from A2920163 through A3185287 and various model numbers. These products were distributed nationwide in the United States as well as in numerous international markets including Canada, the United Kingdom, Australia, and several European and Asian countries.

The recall was initiated because using the Smart Check tool to perform a Smart Setup with these affected cushions may adversely affect the setup process, resulting in an improper cushion setup. If the cushion is over-inflated or under-inflated, it may reduce or eliminate the benefits provided by the cushion. This improper setup increases the risk of injury to the skin or other soft tissue.

Consumers who possess these affected cushions should stop using them immediately. They should contact Roho Inc. for further instructions on how to resolve the issue, such as returning the product or receiving a replacement, in accordance with the company's recall procedures.

The recalled product

Product
ROHO HIGH PROFILE Single Compartment Cushion with Sensor Ready Technology and ROHO MID PROFILE Single Compartment Cushion with Sensor Ready Technology.
Manufacturer
Roho Inc.
Category
Medical Device — Pressure Relief Cushions
Hazard
Affected units
5,646

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

Distribution

Distributed nationwide across the United States.

Related recalls

Same hazard · skin injury

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