medical Class II Updated 2018-11-14

Medtronic Navigation, Inc.-Littleton recalls Medtronic Navigation 0-arm 02 Imaging System interventional

Recalled Product

Medtronic Navigation 0-arm 02 Imaging System interventional fluoroscopic x-ray system: OARM BI70002000 SYS IMAGING 02 Model: BI70002000 OARM BI70002000R SYS IMAGING 02 REFURB Model: BI70002000R


Hazard / Issue

O-arm 02 Imaging Systems correction to software version 4.1.0; new version of the user manual and an Image Acquisition System ("IAS") product label; replacing blown fuse of the new AC power input circuit

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Serial Numbers:C0875 through C2012
View official government recall

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