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

Recall Insight

This FDA Devices action (record #Z-2326-2024) was formally reported on July 17, 2024, with the manufacturer initiating the action on April 29, 2024. It is classified under Moderate severity (Class II), with a current status of Ongoing. Pivotal Health Solutions, Inc. is listed as the recalling firm, operating out of Watertown, SD. Federal records indicate 32 tables units are affected.

The documented reason for this recall is: 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… Distribution data in the federal record shows the product reached: Distributed to CA, FL, TX, ID, GA, and TN. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 2 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.