Class II — Pivotal Health Solutions, Inc.
| Recalling firm | Pivotal Health Solutions, Inc. |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | 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. |
| Product | Quantum Intersegmental Table, Model/Catalog Number: AMQ400H; heated massage table |
| Quantity | 464 units |
| Distribution | Distribution to US nationwide, Canada and Japan. |
| Initiated | 2025-10-09 |
| Classified | 2025-11-24 |
| Recall number | Z-0588-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Pivotal Health Solutions, Inc. (Z-0588-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/97861/
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