Class 2 Device Recall Quantum Intersegmental Table

• Date Initiated by Firm: October 09, 2025
• Date Posted: November 24, 2025
• Recall Status: Open, Classified
• Recall Number: Z-0587-2026
• Recall Event ID: 97861
• Product Classification: Massager, therapeutic, electric - Product Code ISA
• Product: Quantum Intersegmental Table, Model/Catalog Number: Q400; heated massage table
• Code Information: All serial numbers.
• Recalling Firm/ Manufacturer: Pivotal Health Solutions, Inc.; 3003 9th Ave Sw; Watertown SD 57201-8014
• For Additional Information Contact: 605-753-0110
• Manufacturer 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.
• FDA Determined Cause: Device Design
• 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 (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
• Quantity in Commerce: 34 units
• Distribution: Distribution to US nationwide, Canada and Japan.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.