The Recall Desk
HighFDA (Devices)·Z-0274-2019·Announced 2018-10-31

Medtronic Recalls O-arm 1000 2nd Edition Imaging Systems Due to Software Anomalies

Medtronic is recalling 596 O-arm 1000 2nd Edition Imaging Systems worldwide due to reported software anomalies affecting startup, communication, and imaging functions.

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 is classified as FDA Class II, and the source text describes a risk-of-harm product (medical imaging system) with functional anomalies but does not report any specific injuries or illnesses, fitting the 'High' severity criteria.

Plain-English summary

Medtronic Navigation, Inc. is recalling 596 O-arm 1000 2nd Edition Imaging Systems, Model Number Bl70000027100R. The recall covers all serial numbers for this specific model. The O-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging, intended for use where physicians benefit from high-resolution information of anatomic structures and objects with high x-ray attenuation, such as bony anatomy and metallic objects.

The recall was initiated because software anomalies were reported to affect several system functionalities, including startup and shutdown, system and network communication, motion control, image acquisition and output, dose reporting, and logs generation. The affected units are distributed worldwide, including in the United States (specific states listed in the source) and numerous foreign countries.

Medtronic will install software version 3.1.7 on all 2nd edition imaging systems to address the reported anomalies. Healthcare facilities and users should contact Medtronic for details on the software update and to ensure their systems are compliant.

The recalled product

Product
O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027100R SYSTEM lOOV RWK, Model Number Bl70000027100R 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 from
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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