Medtronic O-arm O2 Imaging System Recalled for Loose Detector Panel Screws
Medtronic is recalling one O-arm O2 Imaging System unit in Austria because loose screws may cause the detector panel to contact other parts, leading to noise, vibration, and poor image quality.
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 the hazard involves potential poor image quality and mechanical noise/vibration without reported injuries or illnesses, fitting the criteria for a moderate severity rating.
Plain-English summary
Medtronic Navigation, Inc. is recalling one unit of the O-arm O2 Imaging System (Catalog Number: Bl-700-02000, Serial Number: C0936). The product is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging, intended for use where physicians benefit from high-resolution images of anatomic structures and objects with high x-ray attenuation, such as bony anatomy and metallic objects.
The recall is due to a defect where screws holding the detector panel may be loose. This condition could allow the detector panel to make contact with other parts within the system. Such contact may cause noise and vibration when the system is being positioned or during 3D imaging, which could lead to poor image quality.
The affected unit was distributed to Austria. No injuries or illnesses have been reported in connection with this recall. Users should contact Medtronic Navigation, Inc. for instructions on how to resolve the issue.
The recalled product
- Product
- Medtronic 0-arm 02 Imaging System Catalog Number: Bl-700-02000 The O-arm O2 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 anatomic structures and objects…
- Manufacturer
- Medtronic Navigation, Inc.
- Category
- Medical Device — Imaging System
- Affected units
- 1
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)
- Serial Number: C0936
Distribution
Distribution scope not specified by the agency.
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