Pivotal Health Solutions, Inc.: Decompression Table Model E9011. This device applies cervical and/or lumbar decompression with practitioner definable target treatment location, treatment pounds, and p

Hazard

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.

Details from the source

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 Quantity: 32 tables Lot/code info: UDI-DI 00850008449826; Model Number: E9011; Serial Numbers: WTN-DOC03132457209 WTN-DOC-3132457210, WTN-DOC03132457235, WTN-DOC03132457237, WTN-DOC03132457238, WTN-DOC03132457239 Expanded Recall serial numbers: WTN-DOC04262458492, WTN-DOC04262458490, WTN-DOC04262458487, WTN-DOC04262458488, WTN-DOC04262458489, WTN-DOC0332457239, WTN-DOC04082457899, WTN-DOC04262458484, WTN-DOC03132457238, WTN-DOC03132457237, WTN-DOC03132457210, WTN-DOC04082457897, WTN-DOC04082457898, WTN-DOC03132457201, WTN-DOC04192458307, WTN-DOC04082457896, WTN-DOC03132457209, WTN-DOC03132457235, WTN-DOC04262458496, WTN-DOC03132457240, WTN-DOC03132457241, WTN-DOC04082457882, WTN-DOC04172458185, WTN-DOC04082457893, WTN-DOC04082457894, WTN-DOC04082457895

UPC codes

00850008449826

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.