# FDA recall Z-2326-2024

> **Pivotal Health Solutions, Inc.** · Class II · device recall initiated 2024-04-29.

## 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.

## Distribution

Distributed to CA, FL, TX, ID, GA, and TN

## Key facts

- **Recall number:** Z-2326-2024
- **Recalling firm:** Pivotal Health Solutions, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-04-29
- **Report date:** 2024-07-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Watertown, SD, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2326-2024

## Citation

> AI Analytics. FDA recall Z-2326-2024. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-2326-2024. Source: US FDA. Licensed CC0.

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