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RecallWatchMedical Device Safety
Class IIOngoingZ-0587-2026

Pivotal Health Solutions, Inc. recalls Quantum Intersegmental Table

Pivotal Health Solutions, Inc.Watertown, SD, United StatesReported Dec 3, 2025 · 7 months ago
Legal News Analyst ·

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.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Quantum Intersegmental Table, Model/Catalog Number: Q400; heated massage table

Lot / code information

All serial numbers.

What the firm is doing

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

DistributionShow details

Distribution to US nationwide, Canada and Japan.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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