FEI 3002693132

Agiliti Health - Ellis

204 W 2nd St, ELLIS, KS, US

MDR events26All time

Recalls1All time

Registered products5

Establishment typeManufactureManufacture Medical Device

Registered product codes

5 product codes

Recent MDR events

26 on file

Recalls

1 on file

Open, ClassifiedFeb 26, 2026
Agiliti identified an issue where the Adapt Pump (61600200-Adapt Pump) supplied with all Adapt Line support surfaces does not re-engage the Microclimate Management function after using the Autofirm function for 10 minutes. This issue only occurs when the 10-minute timer is allowed to elapse after the Autofirm button is pressed after initial setup, and it only affects the Microclimate Management function.
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Compliance history

Matched by FEI 3002693132.

FDA inspections

2 on file

Voluntary Action Indicated (VAI)Nov 2, 2023
Compliance: Devices · Citations posted
No Action Indicated (NAI)Nov 2, 2023
Postmarket Assurance: Devices · Citations posted

Inspection citations

2 on file

Top cited requirements

Compare to industry ↗

21 CFR 820.50Nov 2, 2023
Purchasing controls, Lack of or inadequate procedures
21 CFR 820.80(d)Nov 2, 2023
Lack of or inadequate final acceptance procedures

Compliance actions

0 on file

No warning letters or injunctions on file for this FEI number.

Import refusals

0 on file

No import refusals on file for this FEI number.