FDA Enforcement
Class II
Ongoing
Quantum Intersegmental Table, Model/Catalog Number: AMQ400H; heated massage table
Recall: Z-0588-2026
·
Reported December 3, 2025
Enforcement
- Recall Number
- Z-0588-2026
- Event ID
- 97861
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Pivotal Health Solutions, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 3, 2025
- Initiation Date
- October 9, 2025
- Classification Date
- November 24, 2025
- Address
- 3003 9th Ave Sw, N/A, Watertown, SD, 57201-8014, United States
Description
Quantum Intersegmental Table, Model/Catalog Number: AMQ400H; 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.
Code Info
All serial numbers.
Distribution
Distribution to US nationwide, Canada and Japan.
Quantity
464 units