Quantum Intersegmental Table, Model/Catalog Number: AMQ400H; heated massage table
This recall is currently active, issued November 24, 2025. It was issued by Pivotal Health Solutions, Inc..
- Company
- Pivotal Health Solutions, Inc.
- Recall Initiated
- October 9, 2025
- Posted
- November 24, 2025
- Recall Number
- Z-0588-2026
- Quantity
- 464 units
- Firm Location
- Watertown, SD
- Official Source
- View on FDA website ↗
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.
Lot / Code Info
All serial numbers.
Root Cause
Device Design
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