Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0973-2014·Announced 2014-03-12

Medtronic O-arm Imaging System Recalled for Labeling Compliance Gaps

Medtronic is recalling O-arm Imaging Systems because a review found gaps in compliance with FDA labeling requirements for user information.

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 and involves a labeling compliance gap (21 CFR 1020.30(h)) rather than a physical defect or reported injury, fitting the 'Moderate' criteria for minor labeling errors or low-risk issues.

Plain-English summary

Medtronic Navigation, Inc. is recalling the Medtronic O-arm Imaging System, a mobile X-ray system designed for 2D fluoroscopic and 3D imaging. The recall involves Model Nos. BI-700-00027 and BI-700-00028, with serial numbers ranging from 00102 through 00753 and specific serials B13080721, B13080722, B13090729, B13120763, B13120764, B13120766, B13120768, and B13120769. A total of 449 units were distributed nationwide in the United States.

The recall was initiated after a review of on-system electronic product labeling and Instructions for Use, conducted in response to a customer inquiry, uncovered gaps in compliance with FDA standards. Specifically, the devices did not fully meet the requirements for information to be provided to users under 21 CFR 1020.30(h). This is a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Healthcare facilities and users of the affected Medtronic O-arm Imaging Systems should contact Medtronic Navigation, Inc. for further instructions on how to resolve the labeling compliance issues. The recall is limited to the specific model and serial numbers listed above.

The recalled product

Product: Medtronic O-arm Imaging System Mobile X-ray system. Model No. BI-700-00027 and BI-700-00028 The 0-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from 2D and 3D information of…
Manufacturer: Medtronic Navigation, Inc.
Category: Medical Device — Imaging System
Hazard: mis-labeling
Affected units: 449

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 (7)

B13080722
B13090729
B13120763
B13120764
B13120766
B13120768
B13120769

Distribution

Distributed nationwide across the United States.

Same manufacturer · Medtronic Navigation, Inc.

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