Class II

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

Pivotal Health Solutions, Inc. · April 29, 2024

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

States Affected

CA, FL, GA, ID, TN, TX

Quantity Affected

32 tables

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2326-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Pivotal Health Solutions, Inc. Medical Device Recall: Decompression Table Model E9011. This device applies cervical and/or lumbar decompression with practitioner definable target treatment location, treatment pounds, and patterns of treatment. | SafeCheck