Recall Z-2326-2024— Pivotal Health Solutions, Inc.

Name: FDA recall Z-2326-2024
Creator: U.S. Food and Drug Administration
Published: 2024-04-29

Class II · Ongoing

Class II FDA medical device recall by Pivotal Health Solutions, Inc., initiated 2024-04-29. It names one FDA 510(k) clearance: K101889. 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..

Recalling firm: Pivotal Health Solutions, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2024-04-29
Firm location: Watertown, SD, United States

510(k) clearances named in this recall

1 on FDA's record

K101889 — DECOMPRESSION OF CHOICE AND NEURO DECOMPRESSION DEVICEPivotal Health Solutions·cleared 2010-08-27

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.