FDA-Device2025-12-03Class II
Quantum Intersegmental Table, Model/Catalog Number: Q400; heated massage table
Pivotal Health Solutions, Inc.
Hazard
The heat function may become damaged over time due to patients pressing on the areas with heat function components. Damage to components can lead to overheating which can lead to smoldering and melting of the vinyl cushion.
Sold states
Distribution to US nationwide, Canada and Japan.
Affected count
34 units
Manufactured in
3003 9th Ave Sw, N/A, Watertown, SD, United States
Products
Quantum Intersegmental Table, Model/Catalog Number: Q400; heated massage table
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0587-2026Don't want to check this manually?
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