Q400 massage tables recalled over heat components that can overheat
Pivotal Health Solutions is recalling 34 Quantum Intersegmental Tables, model Q400, because damage to the heat function components can lead to overheating and smoldering.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: overheating that can smolder and melt the cushion beneath a patient is a burn and fire hazard, and no injuries are reported.
Plain-English summary
The Quantum Intersegmental Table, model Q400, a heated massage table from Pivotal Health Solutions, is being recalled across all serial numbers.
The heat function may become damaged over time due to patients pressing on the areas with heat function components. The firm states damage to components can lead to overheating, which can lead to smoldering and melting of the vinyl cushion.
The recall covers 34 units. The product was distributed nationwide in the United States and to Canada and Japan. The FDA has classified the action as Class II.
The enforcement record reports no injuries. Clinics operating an affected table should follow the firm's instructions.
The recalled product
- Product
- Quantum Intersegmental Table, Model/Catalog Number: Q400; heated massage table
- Manufacturer
- Pivotal Health Solutions, Inc.
- Category
- Medical Device — Therapy table
- Hazard
- overheating
- smoldering
- burn-risk
- component-damage
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All serial numbers.
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- SevereT-Lok Bone Marrow Tray Kits Recalled for Sterility Testing Failure
FDA (Devices) · 2026-07-22
- SevereMedtronic Bio-Medicus Adult Cannula Kit Recalled for Foreign Material
FDA (Devices) · 2026-07-22
- SevereAbiomed Impella CP Introducer Kit heart pump accessory recall
FDA (Devices) · 2026-07-22
- HighOlympus Toomey Evacuator 50cc with Adaptor sterilization recall
FDA (Devices) · 2026-07-22
- HighVasoview Hemopro 2 Endoscopic Vessel Harvesting System Recall
FDA (Devices) · 2026-07-22