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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94815

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
April 29, 2024
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

1 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 1

Decompression Table Model E9011. This device applies cervical and/or lumbar decompression with practitioner definable target treatment location, treatment pounds, and patterns of treatment.

Z-2326-2024
Recall number
Z-2326-2024
Initiated
April 29, 2024
Classification
Class II
Status
Ongoing
Quantity
32 tables

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
This product is being recalled due to potentially insufficient rework on a part (E7130-B) on the lumbar section of the frame on 6 distributed tables. There were 4 additional tables with the faulty E7130-B part that were manufactured, but had not been distributed yet.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

This product is being recalled due to potentially insufficient rework on a part (E7130-B) on the lumbar section of the frame on 6 distributed tables. There were 4 additional tables with the faulty E7130-B part that were manufactured, but had not been distributed yet.

Code information

UDI-DI 00850008449826; Model Number: E9011; Serial Numbers: WTN-DOC03132457209 WTN-DOC-3132457210, WTN-DOC03132457235, WTN-DOC03132457237, WTN-DOC03132457238, WTN-DOC03132457239 Expanded Recall serial numbers: WTN-DOC04262458492, WTN-DOC04262458490, WTN-DOC04262458487, WTN-DOC04262458488, WTN-DOC04262458489, WTN-DOC0332457239, WTN-DOC04082457899, WTN-DOC04262458484, WTN-DOC03132457238, WTN-DOC03132457237, WTN-DOC03132457210, WTN-DOC04082457897, WTN-DOC04082457898, WTN-DOC03132457201, WTN-DOC04192458307, WTN-DOC04082457896, WTN-DOC03132457209, WTN-DOC03132457235, WTN-DOC04262458496, WTN-DOC03132457240, WTN-DOC03132457241, WTN-DOC04082457882, WTN-DOC04172458185, WTN-DOC04082457893, WTN-DOC04082457894, WTN-DOC04082457895

Distribution pattern

Distributed to CA, FL, TX, ID, GA, and TN