Recall archive / FDA device enforcement
Decompression Table Model E9011. This device applies cervical and/or lumbar decompression with practitioner definable... — FDA record Z-2326-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Apr 29, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Reason
- 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.
- Classification
- Class II
- Recalling firm
- Pivotal Health Solutions, Inc.
- Quantity
- 32 tables
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2326-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Distributed to CA, FL, TX, ID, GA, and TN
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Jul 17, 2024
- Recall initiation date
- Apr 29, 2024
- Center classification date
- Jul 10, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.