Quick Facts at a Glance
- Recall Date
- October 9, 2025
- Hazard Level
- HIGH
- Brand
- Pivotal Health Solutions
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Pivotal Health Solutions
- Product type
- Heated massage table
- Model numbers
- Q400
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
October 9, 2025
Reported by FDA DEVICE
December 3, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
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 You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Pivotal Health Solutions, Inc. or your healthcare provider for instructions. Notification method: Letter
About This Product
The Quantum Intersegmental Table Q400 is a heated massage table used in clinical and therapeutic settings. It is designed to provide heat-assisted therapy to patients during treatments.
Why This Is Dangerous
Prolonged or repeated pressure on heat-function components can damage the heating elements. This can cause overheating, which risks smoldering and melting the vinyl cushion, creating a fire and burn hazard.
Industry Context
This recall is not presented as part of a broader industry pattern.
Real-World Impact
Clinics and patients may need to discontinue use immediately. The recall could affect therapy schedules and equipment budgeting. No injuries reported yet.
Practical Guidance
How to identify if yours is affected
- Confirm model Q400 is in your inventory
- Check that it matches the description of the recalled unit distribution (US nationwide, Canada, Japan)
- Review recall notice for the precise instructions from the manufacturer
- Do not use the device until cleared by the manufacturer
Where to find product info
Refer to the FDA enforcement report for Z-0587-2026 and the manufacturer’s recall communications
What timeline to expect
Refunds or replacements, if offered, typically occur within 4-8 weeks after eligibility is confirmed
If the manufacturer is unresponsive
- Document all contact attempts with the manufacturer
- File a complaint with the CPSC if the company fails to respond
- Consult your healthcare facility compliance officer or legal counsel if needed
How to prevent similar issues
- When buying massage tables, verify heat-control safety features (automatic shutoff)
- Inspect vinyl cushions for signs of heat damage
- Keep devices away from direct heat sources and ensure proper ventilation
- Register equipment with the manufacturer for recall notices
Documentation advice
Keep the recall notice, purchase records, serial numbers, photos of the unit, and all correspondence with the manufacturer.
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Product Details
Model/Catalog Number: Q400 Product: Quantum Intersegmental Table, heated massage table Manufacturer: Pivotal Health Solutions, Inc. Distribution: US nationwide, Canada, Japan Recall date: 2025-10-09 Status: Active Quantity: 34 units Recall number: Z-0587-2026 Remedy: Stop using the device. Follow manufacturer recall instructions. Contact Pivotal Health Solutions or your healthcare provider for instructions.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Distributed in US nationwide, Canada, Japan
- Hazard: overheating of heat function leading to smoldering/melting vinyl
- No injuries or incidents reported
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