Medtronic O-arm O2 Imaging System. Model Number: BI70002000. Medical Device Recalled: Class II Recall Explained

Overview

A medical device recall is an action taken to correct or remove a device from the market when it may pose a health risk or fails to perform as intended. Device recalls range from a simple software patch or a labeling correction to a full removal of the product from circulation, depending on how serious the underlying issue is.

This specific medical device recall involving Medtronic O-arm O2 Imaging System. Model Number: BI70002000. is classified as Class II, and was reported on June 24, 2026 by Medtronic Navigation, Inc.-Boxborough.

The sections below explain, in plain language, what is known about this medical device recall, who it may affect, and what steps patients and caregivers can reasonably take. This article is an independent summary written for educational purposes and is not a substitute for the official FDA notice linked at the end of this page.

What Happened

Medtronic Navigation, Inc.-Boxborough initiated action on Medtronic O-arm O2 Imaging System. Model Number: BI70002000. on June 24, 2026 after identifying a quality or safety concern identified by the manufacturer or the FDA. The action affects specific lots or units of this device rather than every unit ever produced, so not every package on the market is necessarily involved.

The action is described in FDA records as voluntary: firm initiated, and its current status in FDA records is listed as "Ongoing". Recall status can change as the firm works through correction or removal, so the most current information is always the official FDA recall record linked below.

Affected Products

The product identified in this notice is Medtronic O-arm O2 Imaging System. Model Number: BI70002000., manufactured or distributed by Medtronic Navigation, Inc.-Boxborough.

Identifying details on record include specific lot numbers, batch codes, or serial numbers documented as Model Number: BI70002000. GTIN (Serial Numbers): 00643169639683 (C1640), 00643169651814 (C3815, C3816, C3817, C3818, C3891, C3898, C3899, C3900, C3901, C3902, C3903, C3905, C3990, C3997, C3998, C3999, C4001, C4002, C4003, C4004, C4059,…; a reported quantity of 589 units; distribution reported as Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Angola, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Chile, China, Cyprus, Czech…; origin or reporting location of Boxborough, MA, United States. If you have this product, compare it against these identifiers before assuming it is affected — many recalls apply to only a subset of lots, not an entire product line.

Reason

Based on FDA records, this notice was driven by a quality or safety concern identified by the manufacturer or the FDA. In general terms, this kind of issue is flagged because it has the potential to affect how safely or effectively the product performs once it reaches a patient.