Recall Z-0587-2026— Pivotal Health Solutions, Inc.
Class II · Ongoing
Class II FDA medical device recall by Pivotal Health Solutions, Inc., initiated 2025-10-09. FDA's recall record names no specific 510(k) clearance for this event. Product: Quantum Intersegmental Table, Model/Catalog Number: Q400; 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..
- Recalling firm
- Pivotal Health Solutions, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-10-09
- Firm location
- Watertown, SD, United States
Product description
Quantum Intersegmental Table, Model/Catalog Number: Q400; heated massage table
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.