Pivotal Health Solutions, Inc.: Device Recall
Recall #Z-0587-2026 · 10/09/2025
Class II: Risk
Recall Details
- Recall Number
- Z-0587-2026
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Pivotal Health Solutions, Inc.
- Status
- Ongoing
- Date Initiated
- 10/09/2025
- Location
- Watertown, SD, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 34 units
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.
Product Description
Quantum Intersegmental Table, Model/Catalog Number: Q400; heated massage table
Distribution Pattern
Distribution to US nationwide, Canada and Japan.
Other Recalls by Pivotal Health Solutions, Inc.
- Class II: Risk 10/09/2025
- Class II: Risk 04/29/2024
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.