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Pivotal Health Solutions, Inc.: Quantum Intersegmental Table, Model/Catalog Number: AMQ400H; heated massage table

Medical DevicesSource: FDA (device) · Date: 2025-12-03

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Pivotal Health Solutions, Inc.
Product
Quantum Intersegmental Table, Model/Catalog Number: AMQ400H; heated massage table
Reason / hazard
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.
Classification
Class II
Status
Ongoing
Distribution / sold at
Distribution to US nationwide, Canada and Japan.
Recall initiated
2025-10-09
Code info
All serial numbers.
Product quantity
464 units
Voluntary mandated
Voluntary: Firm initiated
City
Watertown
State
SD
Country
United States
Event id
97861
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