← FDA ENFORCEMENT
Z-0587-2026Class II

Pivotal Health Solutions, Inc.

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Pivotal Health Solutions, Inc.
Product type
Device
Status
Ongoing
Report date
2025-12-03
Distribution
Distribution to US nationwide, Canada and Japan.
Firm state
SD
Product quantity
34 units
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

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.

Product description

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

Code / lot info

All serial numbers.

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →