Z-0588-2026 Class II Ongoing
FDA device recall Z-0588-2026 was initiated by Pivotal Health Solutions, Inc. on October 9, 2025 and is designated Class II. 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 meltin… The recall status is ongoing. Affected quantity: 464 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 3, 2025
- Initiation Date
- October 9, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 464 units
Product Description
Quantum Intersegmental Table, Model/Catalog Number: AMQ400H; 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.
Distribution Pattern
Distribution to US nationwide, Canada and Japan.
Code Information
All serial numbers.