FDA recall Z-2326-2024

Pivotal Health Solutions, Inc. · Class II · device

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 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

Key facts

Status
Ongoing
Initiation date
2024-04-29
Report date
2024-07-17
Voluntary/Mandated
Voluntary: Firm initiated
Location
Watertown, SD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2326-2024