CLASS II ONGOING Device recall · Reported 3 Dec 2025 · FDA Enforcement Report

Quantum Intersegmental Table recalled by Pivotal Health Solutions

Pivotal Health Solutions is recalling Quantum Intersegmental Table, distributed nationwide in the US. The recall was initiated on 9 Oct 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll serial numbers.

Quantity recalled34 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0587-2026
FDA event ID: 97861
Recalling firm: Pivotal Health Solutions, Watertown, SD
Classification: Class II
Status: Ongoing
Recall initiated: 9 Oct 2025
FDA classified: 24 Nov 2025
Reported: 3 Dec 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

9 Oct 2025	Recall initiated by company
24 Nov 2025	Classified by FDA	+46 days
3 Dec 2025	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

Quantum Intersegmental Table, Model/Catalog Number: Q400; heated massage table

Where it was distributed

Distribution to US nationwide, Canada and Japan.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

All serial numbers.

Where was it sold?

Distribution to US nationwide, Canada and Japan.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 97861

Reported	Class	Recall	Company	Reason	Where
3 Dec 2025	CLASS II	Quantum Intersegmental Table recalled by Pivotal Health Solutions	Pivotal Health Solutions	Other	Nationwide

Reported	Class	Recall	Company	Reason	Where
3 Dec 2025Device	CLASS II	Quantum Intersegmental Table recalled by Pivotal Health Solutions	Pivotal Health Solutions	Other	Nationwide
17 Jul 2024Device	CLASS II	Decompression Table recalled by Pivotal Health Solutions	Pivotal Health Solutions	Other	6 states
18 Mar 2015Device	CLASS II	Apollo (cold) Laser Desktop Control Units recalled	Pivotal Health Solutions	Device Malfunction	17 states

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