Recall Z-2326-2024 ยท ITH Equipment, Traction, Powered
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 patterns of treatment.
| Date | Jul 10, 2024 (initiated Apr 29, 2024) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| Action | 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 con |
| Quantity | 32 tables |
| Distribution | Distributed to CA, FL, TX, ID, GA, and TN |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101889 | DECOMPRESSION OF CHOICE AND NEURO DECOMPRESSION DEVICE Pivotal Health Solutions, Aug 27, 2010 |