FDA Recall Open, Classified

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

Recall: Z-0588-2026 · Initiated October 9, 2025

Recall

Recall Number
Z-0588-2026
Event Number
97861
Firm
Pivotal Health Solutions, Inc.
FEI Number
3007278668
Product Code
ISA
Status
Open, Classified
Root Cause
Device Design
Initiated
October 9, 2025
Posted
November 24, 2025
Address
3003 9th Ave Sw, Watertown, SD, 57201-8014

Description

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

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.

Action

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 ([email protected]) or Julee Driver ([email protected]), Quality Dept, at 605-753-0110 o Brenda Anderson ([email protected]), Service Dept at 605-753-0110

Distribution

Distribution to US nationwide, Canada and Japan.

Quantity

464 units