FDA Medical devices recall ·
Quantum Intersegmental Table, Model recall
- Recall number
- Z-0588-2026
- Date
- (initiated October 9, 2025)
- Company / brand
- Pivotal Health Solutions, Inc.
3003 9th Ave Sw, Watertown, SD, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 464 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Quantum Intersegmental Table, Model/Catalog Number: AMQ400H; heated massage table
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
All serial numbers.
Distribution
Distribution to US nationwide, Canada and Japan.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0588-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.