Z-2326-2024Class II

Decompression Table Model E9011. This device applies cervical and/or lumbar decompression with practitioner...

Name: Z-2326-2024 Decompression Table Model E9011. This device applies cervical and/or lumbar decompression with practitioner...
Creator: Pivotal Health Solutions, Inc.
Published: 2024-04-29
License: https://open.fda.gov/license/

Pivotal Health Solutions / initiated 2024-04-29 / Open, Classified / root cause: manufacturing process

FDA source

Pivotal Health Solutions, Inc. began a recall of Decompression Table Model E9011. This device applies cervical and/or lumbar decompression with practitioner definable target treatment location, treatment... on 2024-04-29. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2326-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-04-29
Posted: 2024-07-10
Recalling firm: Pivotal Health Solutions
Product: Decompression Table Model E9011. This device applies cervical and/or lumbar decompression with practitioner definable target treatment location, treatment pounds, and patterns of treatment.
Product code: ITH Equipment, Traction, Powered
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Consignees were initially notified of the recall via phone call starting on 4/29/2024. A followup email or certified mail were sent to the consignees on 6/11/2024. Customers were instructed that Fed Ex was contacted for pickup of the table so the table can be packaged and returned to Pivotal Health Solutions at 3003 9th Ave. SW, Watertown, SD 57201. A recall expansion led to a second updated recall notification being sent to consignees beginning on June 26, 2024 via email. This letter instructs the consignees to stop using the tables listed in the letter. The firm will be contacting the consignees to schedule an engineer to come out to the consignee site to inspect the table(s). The table(s) will be replaced in found to contain an affected part. The consignee is also asked to return a response form.
Quantity in commerce: 32 tables
Distribution: Distributed to CA, FL, TX, ID, GA, and TN
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2326-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2326-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-17	2024-07-10

Product code ITH

K101889Class IIDecompression of Choice and Neuro Decompression DevicePivotal Health Solutions / cleared 2010-08-27

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)