Decompression Table Model E9011. This device applies cervical and/or lumbar decompression with practitioner definable ta

FDA device recall Z-2326-2024 · posted 2024-07-10 · Open, Classified

Recall details

Recalling firm

Pivotal Health Solutions, Inc.

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.

Action taken

Consignees were initially notified of the recall via phone call starting on 4/29/2024. A followup email or certified mail were sent to the consignees on 6/11/2024. Customers were instructed that Fed Ex was contacted for pickup of the table so the table can be packaged and returned to Pivotal Health Solutions at 3003 9th Ave. SW, Watertown, SD 57201. A recall expansion led to a second updated recall notification being sent to consignees beginning on June 26, 2024 via email. This letter instructs the consignees to stop using the tables listed in the letter. The firm will be contacting the consignees to schedule an engineer to come out to the consignee site to inspect the table(s). The table(s) will be replaced in found to contain an affected part. The consignee is also asked to return a response form.

Root cause

Nonconforming Material/Component

Status

Open, Classified

Product code

ITH

Quantity affected

32 tables

Distribution

Distributed to CA, FL, TX, ID, GA, and TN

Date initiated

2024-04-29

Date posted

2024-07-10

Location

Watertown, SD

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