HIGH

Pivotal Health Solutions Recalls Q400 Heated Massage Table Due to Overheating Risk

Pivotal Health Solutions recalled 34 heated massage tables on October 9, 2025. The heat function may overheat, posing a risk of smoldering and melting. Affected units are distributed nationwide in the U.S., Canada, and Japan.

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

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

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Product Details

The recall involves the Quantum Intersegmental Table, Model Q400. The tables were distributed nationwide in the U.S., Canada, and Japan. All serial numbers are affected.

The Hazard

The heat function may sustain damage from pressure applied by patients, leading to overheating. This can result in smoldering and melting of the vinyl cushion, creating a serious safety risk.

Reported Incidents

No specific incidents or injuries have been reported at this time. The recall is precautionary due to the risk of overheating.

What to Do

Stop using the heated massage table immediately. Contact Pivotal Health Solutions, Inc. or your healthcare provider for instructions on the recall.

Contact Information

For more information, visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0587-2026.

Key Facts

  • 34 units recalled
  • Affected model: Q400
  • Risk of smoldering and melting vinyl cushion
  • Distributed in U.S., Canada, Japan
  • Stop use immediately

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
BURN

Product Classification

Product Details

Model Numbers
All serial numbers.
Affected States
ALL
Report Date
December 3, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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