Facility

Pivotal Health Solutions

3 recall(s) on record — most severe on record: Class II.

Key facts

3recalls · worst Class II

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3003365828
Establishment type	Manufacture Medical Device
Location	800 48th St. Springfield, OR, US 97478
Registration status	Active · expires 2026
Parent company	Pivotal Health Solutions, Inc. (owner-operator 10030456)

Activity by year

Recalls (3)

Devices registered here (1)

Chair And Table, Medical
Product code KMN (opens in a new tab) · Class I · General Hospital · 21 CFR 880.6140

Recalls & enforcement

Class IIOngoing2025-10-09
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.
Class IIOngoing2024-04-29
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.
Class IITerminated2014-12-17
Control units were equipped with an internal mounting kit that does not meet medical safety standards, and are conductive, increasing the risk of electric shock to the user and patient. These units were manufactured prior to Pivotal Health Solutions acquisition of the Apollo prod…

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Pivotal Health Solutions (FEI 3003365828) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3003365828-pivotal-health-solutions/

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