Recall Z-0588-2026 ยท ISA Massager, Therapeutic, Electric
Pivotal Health Solutions, Inc.
Quantum Intersegmental Table, Model/Catalog Number: AMQ400H; heated massage table
| Date | Nov 24, 2025 (initiated Oct 9, 2025) |
| Status | Open, Classified |
| 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. |
| Root cause | Device Design |
| Action | Pivotal Health Solutions issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees on 10/9/2025 via certified mail and Fed Ex. The notice explained the issue with the device, risk to health and requested the following: Immediately stop using table(s) with heat. The heat function must be disabled. You have been identified as having been sold a Quantum Table with heat. The serial numbers of the tables impacted are below. If you are unsure if your table has a heat function, please identify the serial number on the Quantum table(s), located on the lower section of table by the power cab |
| Quantity | 464 units |
| Distribution | Distribution to US nationwide, Canada and Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.