FDA Device recall Z-2326-2024
Decompression Table Model E9011
- FDA Device
- Class II
- ongoing
- Published 2024-07-17
On 2024-07-17 the FDA classified a Class II recall of Decompression Table Model E9011 by Pivotal Health Solutions, citing 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 table….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2326-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-04-29 |
| Published | 2024-07-17 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Pivotal Health Solutions |
| Distribution | CA, FL, GA, ID, TN, TX |
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.
Identifiers
| code_info | UDI-DI 00850008449826; Model Number: E9011; Serial Numbers: WTN-DOC03132457209 WTN-DOC-3132457210, WTN-DOC03132457235,…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2326-2024%22
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