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
- Recall Number
- Z-2326-2024
- Event Number
- 94815
- Firm
- Pivotal Health Solutions, Inc.
- FEI Number
- 3007278668
- Product Code
- ITH
- Status
- Open, Classified
- Root Cause
- Nonconforming Material/Component
- Initiated
- April 29, 2024
- Posted
- July 10, 2024
- Address
- 3003 9th Ave Sw, Watertown, SD, 57201-8014
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.
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.
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.
Distributed to CA, FL, TX, ID, GA, and TN
32 tables