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Matrx Libra Adjust Cushion

Motion Concepts Inc · Model LC-ADJ · UDI-DI 07540147001018

KIC

510(k) clearances

177

Adverse events (4 deaths)

Recalls

130

Facilities

Description

Matrx Libra Adjust Seat Cushion (includes 2 fluid supplement packs). Adjustable Skin Protection & Positioning Cushion (standard and bariatric sizing). The Matrx Libra cushion uses a combination of high resilient foam and dual layer fluid sac to provide maximum protection around boney prominences and stability to the pelvis. Recommended for all users including those at highest risk of skin breakdown

Recalls

Date	Firm	Reason
2017-03-20	Roho 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.