Watertown, SD, United States
Pivotal Health Solutions, Inc. recalls
2 recalls recorded since 2018, most recently on 9 October 2025. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)2
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 9 October 2025
- Reason
- The heat function may become damaged over time due to patients pressing on the areas with heat function components. Damage to components can lead to overheating which can lead to smoldering and melting of the vinyl cushion.
- Distribution
- Distribution to US nationwide, Canada and Japan.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0587-2026, Z-0588-2026
- Quantum Intersegmental Table, Model/Catalog Number: Q400; heated massage table
- Quantum Intersegmental Table, Model/Catalog Number: AMQ400H; heated massage table
Ongoing Class II Medical devices
- Recall started
- 29 April 2024
- 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.
- Distribution
- Distributed to CA, FL, TX, ID, GA, and TN
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2326-2024
- Decompression Table Model E9011. This device applies cervical and/or lumbar decompression with practitioner definable target treatment location, treatment pounds, and patterns of treatment.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.