Decompression Table Model E9011 — Class II medical device recall Z-2326-2024
Ongoing recall by Pivotal Health Solutions, Inc., reported 2024-07-17, distributed in CA, FL, GA, ID, TN, TX. This product is being recalled due to potentially insufficient rework on a part (E7130-B) on the lumbar sectio
| Recall number | Z-2326-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pivotal Health Solutions, Inc., Watertown, SD, United States |
| Recall initiated | 2024-04-29 |
| Classified | 2024-07-10 |
| Reported by FDA | 2024-07-17 |
| Distributed | CA, FL, GA, ID, TN, TX |
| Quantity | 32 tables |
| UPC / GTIN / UDI-DI | 00850008449826 |
| Serial numbers | WTN-DOC-3132457210, WTN-DOC03132457201, WTN-DOC03132457209, WTN-DOC03132457210, WTN-DOC03132457235, WTN-DOC03132457237, WTN-DOC03132457238, WTN-DOC03132457239, WTN-DOC03132457240, WTN-DOC03132457241, WTN-DOC0332457239, WTN-DOC04082457882, WTN-DOC04082457893, WTN-DOC04082457894, WTN-DOC04082457895, WTN-DOC04082457896, WTN-DOC04082457897, WTN-DOC04082457898, WTN-DOC04082457899, WTN-DOC04172458185, WTN-DOC04192458307, WTN-DOC04262458484, WTN-DOC04262458487, WTN-DOC04262458488, WTN-DOC04262458489 and 3 more |
| Model numbers | E9011 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2326-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.