FDA recall Z-0587-2026

Pivotal Health Solutions, Inc. · Class II · device

Product

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

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.

Distribution

Distribution to US nationwide, Canada and Japan.

Key facts

Status: Ongoing
Initiation date: 2025-10-09
Report date: 2025-12-03
Voluntary/Mandated: Voluntary: Firm initiated
Location: Watertown, SD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0587-2026