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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices

Pivotal Health Solutions, Inc.: E9011 Decompression Tables Recalled for Potential Structural Frame Failure

Agency Publication Date: July 10, 2024
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Summary

Pivotal Health Solutions is recalling approximately 32 Model E9011 Decompression Tables because a specific part (E7130-B) on the lumbar section of the frame may have been improperly repaired during manufacturing. This defect affects 6 tables that were distributed and 26 additional units listed in the expanded recall. These tables are used by healthcare practitioners to provide cervical and lumbar decompression treatments.

Risk

The potentially faulty lumbar frame part could fail or break during a decompression treatment. If the frame fails while a patient is undergoing therapy, it could lead to unexpected movement or a loss of support, posing a risk of physical injury to the patient or practitioner.

What You Should Do

  1. Identify if your decompression table is affected by checking the model and serial number on the device's identification plate. This recall specifically affects Model E9011 with UDI-DI 00850008449826.
  2. Check your table against the following serial numbers: WTN-DOC03132457209, WTN-DOC-3132457210, WTN-DOC03132457235, WTN-DOC03132457237, WTN-DOC03132457238, WTN-DOC03132457239, WTN-DOC04262458492, WTN-DOC04262458490, WTN-DOC04262458487, WTN-DOC04262458488, WTN-DOC04262458489, WTN-DOC0332457239, WTN-DOC04082457899, WTN-DOC04262458484, WTN-DOC04082457897, WTN-DOC04082457898, WTN-DOC03132457201, WTN-DOC04192458307, WTN-DOC04082457896, WTN-DOC04262458496, WTN-DOC03132457240, WTN-DOC03132457241, WTN-DOC04082457882, WTN-DOC04172458185, WTN-DOC04082457893, WTN-DOC04082457894, and WTN-DOC04082457895.
  3. If your serial number is listed, contact Pivotal Health Solutions immediately to discuss the safety of the unit and to arrange for inspection or repair of the lumbar frame part (E7130-B).
  4. Healthcare providers should contact their patients if they believe a device failure occurred during a previous treatment session.
  5. For further instructions regarding repairs or potential refunds, contact Pivotal Health Solutions at their Watertown, South Dakota headquarters or through their official service channels.
  6. For additional information or to report issues, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer initiated rework/repair for faulty lumbar frame parts.

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Decompression Table Model E9011
Model / REF:
E9011
UPC Codes:
00850008449826
Lot Numbers:
WTN-DOC03132457209
WTN-DOC-3132457210
WTN-DOC03132457235
WTN-DOC03132457237
WTN-DOC03132457238
WTN-DOC03132457239
WTN-DOC04262458492
WTN-DOC04262458490
WTN-DOC04262458487
WTN-DOC04262458488
WTN-DOC04262458489
WTN-DOC0332457239
WTN-DOC04082457899
WTN-DOC04262458484
WTN-DOC04082457897
WTN-DOC04082457898
WTN-DOC03132457201
WTN-DOC04192458307
WTN-DOC04082457896
WTN-DOC04262458496
WTN-DOC03132457240
WTN-DOC03132457241
WTN-DOC04082457882
WTN-DOC04172458185
WTN-DOC04082457893
WTN-DOC04082457894
WTN-DOC04082457895

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94815
Status: Active
Manufacturer: Pivotal Health Solutions, Inc.
Sold By: Pivotal Health Solutions, Inc.
Manufactured In: United States
Units Affected: 32 tables
Distributed To: California, Florida, Texas, Idaho, Georgia, Tennessee

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.