Pivotal Health Solutions, Inc.: Device Recall

Recall Details

Recall Number

Z-2326-2024

Classification

Class II

Product Type

Device

Recalling Firm

Pivotal Health Solutions, Inc.

Status

Ongoing

Date Initiated

04/29/2024

Location

Watertown, SD, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

32 tables

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.

Product Description

Decompression Table Model E9011. This device applies cervical and/or lumbar decompression with practitioner definable target treatment location, treatment pounds, and patterns of treatment.

Distribution Pattern

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

Other Recalls by Pivotal Health Solutions, Inc.

• Class II: Risk 10/09/2025
  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.
• Class II: Risk 10/09/2025
  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.

View all recalls by Pivotal Health Solutions, Inc. →