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Recall Observatory FDA recall evidence

Device product

Quantum Intersegmental Table, Model/Catalog Number: Q400; heated massage table

Z-0587-2026

October 09, 2025

Class II

Product summary

Firm
Pivotal Health Solutions, Inc.
Event
Event 97861
Status
Ongoing
Classification
Class II
Quantity
34 units
Official record key
device-enforcement:Z-0587-2026

Official wording

Reason: 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.

Code information: All serial numbers.

Distribution pattern: Distribution to US nationwide, Canada and Japan.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.