Quantum Intersegmental Table — Class II medical device recall Z-0588-2026
Ongoing recall by Pivotal Health Solutions, Inc., reported 2025-12-03, distributed nationwide. The heat function may become damaged over time due to patients pressing on the areas with heat function compon
| Recall number | Z-0588-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pivotal Health Solutions, Inc., Watertown, SD, United States |
| Recall initiated | 2025-10-09 |
| Classified | 2025-11-24 |
| Reported by FDA | 2025-12-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, JP |
| Quantity | 464 units |
| Reason classes | device malfunction |
| Model numbers | AMQ400H |
Product
Quantum Intersegmental Table, Model/Catalog Number: AMQ400H; heated massage table
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0588-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.