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 software anomalies affecting startup, motion control, and image acquisition.
What this means for you
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 indicates a situation where use of the product may cause temporary or medically reversible health consequences. The source text describes software anomalies but does not report any specific injuries, illnesses, or deaths, aligning with a moderate severity rating for a voluntary precautionary software fix.
Plain-English summary
Medtronic Navigation, Inc. is recalling 596 O-arm 1000 2nd Edition Imaging Systems, Model Number Bl70000027GER. The recall is due to reported software anomalies that affect system functionalities including startup and shutdown, system and network communication, motion control, image acquisition and output, dose reporting, and logs generation.
The affected products were distributed worldwide, including in the United States and numerous foreign countries. 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 a physician benefits from detailed information of anatomic structures and objects with high x-ray attenuation.
Medtronic will install software version 3.1.7 on all 2nd edition imaging systems to address the reported anomalies. Users of these systems should contact Medtronic for further instructions regarding the software update.
The recalled product
- Product
- O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027GER SYS PRODUCT GER, Model Number Bl70000027GER 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 2
- Manufacturer
- Medtronic Navigation, Inc.-Littleton
- Category
- Medical Device — Imaging System
- 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
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.
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