The Recall Desk
HighFDA (Devices)·Z-0276-2019·Announced 2018-10-31

Medtronic O-arm 1000 2nd Edition Imaging System Software Recall

Medtronic is recalling O-arm 1000 2nd Edition Imaging Systems due to software anomalies affecting startup, communication, and image acquisition.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with software anomalies affecting critical functions like image acquisition and motion control, representing a risk of harm where injury has not yet been reported.

Plain-English summary

Medtronic Navigation, Inc. is recalling the O-arm 1000 2nd Edition Imaging System, Model Number Bl70000027120R. The recall involves 596 units distributed worldwide, including in the United States and numerous foreign countries. The O-arm is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging, intended for use where a physician benefits from high-resolution imaging of anatomic structures and objects with high x-ray attenuation.

The recall is due to reported software anomalies that affect several system functionalities, including startup and shutdown, system and network communication, motion control, image acquisition and output, dose reporting, and logs generation. The source text does not report any specific injuries, illnesses, or deaths associated with these anomalies.

To address the issue, software version 3.1.7 will be installed on all 2nd edition imaging systems. Healthcare facilities and users should contact Medtronic Navigation, Inc. for instructions on installing the updated software.

The recalled product

Product
O-arm 1000 2nd Edition Imaging System, BASE BASE OARM Bl70000027120R SYSTEM 120V RWK, Model Number Bl70000027120R Product Usage: The O-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
Manufacturer
Medtronic Navigation, Inc.-Littleton
Category
Medical Device — Imaging System
Hazard
Affected units
596

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)

  • All Serial Numbers

Distribution

Distributed in 45 states:

Part of a larger recall action

This product is one of 10 recalled by Medtronic Navigation, Inc.-Littleton under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 10 products in this recall →

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