Pivotal Health Solutions, Inc.: Medical Device Recall in 2025 - (Recall #: Z-0588-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

Quantum Intersegmental Table, Model/Catalog Number: AMQ400H; heated massage table

Product Classification:

Class II

Date Initiated: October 9, 2025

Date Posted: December 3, 2025

Recall Number: Z-0588-2026

Event ID: 97861

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.

Status: Ongoing

Product Quantity: 464 units

Code Information:

All serial numbers.

Distribution Pattern:

Distribution to US nationwide, Canada and Japan.

Voluntary or Mandated:

Voluntary: Firm initiated