FEI 3004785967

Medtronic Navigation, Inc. (boxborough)

200 Beaver Brook Rd, Boxborough, MA, US

MDR events931All time

Recalls2All time

Registered products4

Establishment typeRemanufactureRemanufacture Medical Device

Registered product codes

4 product codes

Recent MDR events

931 on file

Recalls

2 on file

Open, ClassifiedJun 15, 2026
Potential for image artifacts caused by an anomaly in the O-arm O2 Imaging System s detector panel firmware.
View FDA record ↗
Open, ClassifiedJul 9, 2025
A mechanical component that supports the O2 gantry to the support structure in affected devices may have been damaged during manufacture.
View FDA record ↗

Compliance history

Matched by FEI 3004785967.

FDA inspections

3 on file

No Action Indicated (NAI)Jun 11, 2024
Compliance: Devices · Citations posted
Voluntary Action Indicated (VAI)Jun 11, 2024
Postmarket Assurance: Devices · Citations posted
No Action Indicated (NAI)Jun 11, 2024
Radiation Control and Health Safety Act · Citations posted

Inspection citations

2 on file

Top cited requirements

Compare to industry ↗

21 CFR 803.50(a)(2)Jun 11, 2024
Individual Report of Malfunction
21 CFR 820.184Jun 11, 2024
DHR - not or inadequately maintained

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.