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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 97861

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
October 09, 2025
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Pivotal Health Solutions, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

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

Z-0587-2026
Recall number
Z-0587-2026
Initiated
October 09, 2025
Classification
Class II
Status
Ongoing
Quantity
34 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

All serial numbers.

Distribution pattern

Distribution to US nationwide, Canada and Japan.

device · product 2 of 2

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

Z-0588-2026
Recall number
Z-0588-2026
Initiated
October 09, 2025
Classification
Class II
Status
Ongoing
Quantity
464 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

All serial numbers.

Distribution pattern

Distribution to US nationwide, Canada and Japan.