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.
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. The source text describes software anomalies affecting system functions but does not report any injuries, illnesses, or deaths, fitting the criteria for a moderate severity recall involving potential performance issues without confirmed harm.
Plain-English summary
Medtronic Navigation, Inc. is recalling 596 O-arm 1000 2nd Edition Imaging Systems, Model Number Bl70000027120, due to reported software anomalies. The affected systems are mobile x-ray devices designed for 2D fluoroscopic and 3D imaging, intended for use in surgical settings where physicians require detailed anatomic information.
The software anomalies affect several system functionalities, including startup and shutdown, system and network communication, motion control, image acquisition and output, dose reporting, and log generation. The recall covers all serial numbers of the 2nd Edition systems.
The products were distributed worldwide, including in the United States (all 50 states, DC, and Puerto Rico) and numerous foreign countries. Medtronic will install software version 3.1.7 on all affected 2nd edition imaging systems to address the issues.
The recalled product
- Product
- O-arm 1000 2nd Edition Imaging System, BASE OARM Bl70000027120 SYSTEM 120V, Model Number Bl70000027120 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 2D…
- Manufacturer
- Medtronic Navigation, Inc.-Littleton
- Category
- Medical Device — Imaging Systems
- 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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