Z-0588-2026Class II

Quantum Intersegmental Table, Model/Catalog Number: AMQ400H; heated massage table

Name: Z-0588-2026 Quantum Intersegmental Table, Model/Catalog Number: AMQ400H; heated massage table
Creator: Pivotal Health Solutions, Inc.
Published: 2025-10-09
License: https://open.fda.gov/license/

Pivotal Health Solutions / initiated 2025-10-09 / Open, Classified / root cause: design

FDA source

Pivotal Health Solutions, Inc. began a recall of Quantum Intersegmental Table, Model/Catalog Number: AMQ400H; heated massage table on 2025-10-09. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0588-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-10-09
Posted: 2025-11-24
Recalling firm: Pivotal Health Solutions
Product: Quantum Intersegmental Table, Model/Catalog Number: AMQ400H; heated massage table
Product code: ISA Massager, Therapeutic, Electric
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.
Root cause tag: design
FDA 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 cable inlet, and verify the serial number is on the list. The notice also supplied instructions for disconnecting and disabling the heat function o the Q400 tables. Contact information for questions: o Matt White ([email protected]) or Julee Driver ([email protected]), Quality Dept, at 605-753-0110 o Brenda Anderson ([email protected]), Service Dept at 605-753-0110
Quantity in commerce: 464 units
Distribution: Distribution to US nationwide, Canada and Japan.
Product codes and lots: All serial numbers.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0588-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0587-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-03	2025-11-24
Z-0588-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-03	2025-11-24

Product code ISA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)