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

FDA device recall Z-0588-2026 · posted 2025-11-24 · Open, Classified

Recall details

Recalling firm

Pivotal Health Solutions, Inc.

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.

Action taken

Pivotal Health Solutions issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees on 10/9/2025 via certified mail and Fed Ex. The notice explained the issue with the device, risk to health and requested the following: Immediately stop using table(s) with heat. The heat function must be disabled. You have been identified as having been sold a Quantum Table with heat. The serial numbers of the tables impacted are below. If you are unsure if your table has a heat function, please identify the serial number on the Quantum table(s), located on the lower section of table by the power cable inlet, and verify the serial number is on the list. The notice also supplied instructions for disconnecting and disabling the heat function o the Q400 tables. Contact information for questions: o Matt White (matt.white@pivotalhealthsolutions.com) or Julee Driver (julee.driver@pivotalhealthsolutions.com), Quality Dept, at 605-753-0110 o Brenda Anderson (brenda.anderson@pivotalhealthsolutions.com), Service Dept at 605-753-0110

Root cause

Device Design

Status

Open, Classified

Product code

ISA

Quantity affected

464 units

Distribution

Distribution to US nationwide, Canada and Japan.

Date initiated

2025-10-09

Date posted

2025-11-24

Location

Watertown, SD