ROHO HIGH PROFILE Single Compartment Cushion with Sensor Ready… — Class II medical device recall Z-1921-2017
Terminated recall by Roho Inc., reported 2017-05-10, distributed nationwide. When the Smart Check tool is used to perform a Smart Setup with one of the affected cushions, it may adversely
| Recall number | Z-1921-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Roho Inc., Belleville, IL, United States |
| Recall initiated | 2017-03-20 |
| Classified | 2017-05-02 |
| Reported by FDA | 2017-05-10 |
| Terminated | 2019-05-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, CA, CH, CZ, DE, ES, FI, FR, GB, HK, IE, IS, IT, JP, KR, LU, NZ, SE, SG, ZA |
| Quantity | 5,646 units |
| Serial numbers | A2920163 |
| Model numbers | 1R1010H-CA-SC, 1R1010H-CA-SCDM, 1R1010H-CA-SR, 1R1010H-CF-SCDM, 1R1010H-CF-SR, 1R1010H-CH-SR, 1R1010M-CA-SC, 1R1010M-CA-SCDM, 1R1010M-CA-SR, 1R1010M-CF-SCDM, 1R1010M-CF-SR, 1R1010M-CH-SR, 1R1011H-CA-SC, 1R1011H-CA-SR, 1R1011H-CF-SR, 1R1011H-CH-SC, 1R1011H-CH-SR, 1R1011M-CA-SC, 1R1011M-CA-SR, 1R1011M-CF-SR, 1R1012H-CA-SR, 1R1012H-CF-SR, 1R1012H-CH-SR, 1R108H-CA-SR, 1R108H-CF-SR and 97 more |
Product
ROHO HIGH PROFILE Single Compartment Cushion with Sensor Ready Technology and ROHO MID PROFILE Single Compartment Cushion with Sensor Ready Technology.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1921-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.