Quantum Intersegmental Table, Model/Catalog Number: Q400; heated massage table
Summary
The FDA issued a Class II for Quantum Intersegmental Table, Model/Catalog Number: Q400; heated massage table by Pivotal Health Solutions, Inc.. 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 o.
Details
Source
Device Recall
External ID
Z-0587-2026
Action Date
2025-12-03
Status
Ongoing
Category
device
Product Description
Quantum Intersegmental Table, Model/Catalog Number: Q400; heated massage table
Lot/Code Info: All serial numbers.
Quantity Affected: 34 units
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.
Distribution
Distribution to US nationwide, Canada and Japan.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-10-09
Company
Watertown, SD
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 254 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Pivotal Health Solutions, Inc. has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Pivotal Health Solutions, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Pivotal Health Solutions, Inc. have FDA actions?
Pivotal Health Solutions, Inc. has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0587-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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