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ROHO HIGH PROFILE Single Compartment Cushion

Roho, Inc. · Model 1R1213HD · UDI-DI 00613732115487

KIC
10
510(k) clearances
172
Adverse events (4 deaths)
1
Recalls
130
Facilities

Recalls

DateFirmReason
2017-03-20Roho Inc.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. Sitt

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.