Medtronic Navigation 0-arm 02 Imaging System Software and Hardware Recall
Medtronic Navigation is recalling 641 O-arm 02 Imaging Systems to correct software version 4.1.0, update manuals and labels, and replace blown fuses in the AC power input circuit.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a Moderate severity score when no specific hospitalizations or significant injuries are reported in the source text.
Plain-English summary
Medtronic Navigation, Inc. is recalling 641 O-arm 02 Imaging Systems, including models BI70002000 and BI70002000R. The affected serial numbers range from C0875 through C2012. These interventional fluoroscopic x-ray systems were distributed worldwide, including in the United States and numerous foreign countries.
The recall is initiated to correct the software to version 4.1.0, provide a new version of the user manual and an Image Acquisition System (IAS) product label, and replace the blown fuse of the new AC power input circuit. This action addresses specific software and hardware components of the imaging system.
Healthcare facilities and users should contact Medtronic Navigation for instructions on how to obtain the software correction, updated documentation, and hardware replacement. The recall is classified as Class II by the FDA, indicating that use of the product could, in some cases, cause temporary or medically reversible adverse health consequences.
The recalled product
- 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
- Manufacturer
- Medtronic Navigation, Inc.-Littleton
- Category
- Medical Device — Imaging System
- Affected units
- 641
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Serial Numbers:C0875 through C2012
Distribution
Distributed nationwide across the United States.
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