FDA Medical Device Recalls (openFDA)
Pivotal Health Solutions, Inc.: Quantum Intersegmental Table, Model/Catalog Number: Q400; heated massage table
- Recall number
- Z-0587-2026
- Recalling firm
- Pivotal Health Solutions, Inc.
- Product
- Quantum Intersegmental Table, Model/Catalog Number: Q400; heated massage table
- Status
- Open, Classified
- Initiated
- 2025-10-09
- Posted
- 2025-11-24
- Terminated
- not on file
- Reason
- The heat function may become damaged over time due to patients pressing on the areas with heat function components. Damage to components can lead to overheating which can lead to smoldering and melting of the vinyl cushion.
- Root cause
- Device Design
- Action
- Pivotal Health Solutions issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees on 10/9/2025 via certified mail and Fed Ex. The notice explained the issue with the device, risk to health and requested the following: Immediately stop using table(s) with heat. The heat function must be disabled. You have been identified as having been sold a Quantum Table with heat. The serial numbers of the tables impacted are below. If you are unsure if your table has a heat function, please identify the serial number on the Quantum table(s), located on the lower section of table by the power cable inlet, and verify the serial number is on the list. The notice also supplied instructions for disconnecting and disabling the heat function o the Q400 tables. Contact information for questions: o Matt White (matt.white@pivotalhealthsolutions.com) or Julee Driver (julee.driver@pivotalhealthsolutions.com), Quality Dept, at 605-753-0110 o Brenda Anderson (brenda.anderson@pivotalhealthsolutions.com), Service Dept at 605-753-0110
- Quantity
- 34 units
- Distribution
- Distribution to US nationwide, Canada and Japan.
- Lot, serial or model codes
- All serial numbers.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- ISA
- Firm FEI
- 3007278668
- Firm city
- Watertown
- Firm state
- SD
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28