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, motion control, and image acquisition.
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 3/5 (High).
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 high-risk medical device (imaging system) with functional defects affecting motion control and image acquisition, but the source text does not report any injuries or illnesses, fitting the 'risk-of-harm products where injury has not yet been reported' criterion.
Plain-English summary
Medtronic Navigation, Inc. is recalling 596 O-arm 1000 2nd Edition Imaging Systems, Model Number Bl70000027R. 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. Medtronic states that software version 3.1.7 will be installed on all 2nd edition imaging systems to address the issue.
Healthcare facilities and users of these systems should contact Medtronic Navigation, Inc. for instructions on how to obtain the software update. The source text does not report any specific injuries or illnesses associated with these software anomalies.
The recalled product
- Product
- O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027R SYS PRODUCT RWK, Model Number Bl70000027R 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 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.
See all 10 products in this recall →Related recalls
Same manufacturer · Medtronic Navigation, Inc.-Littleton
See all →- ModerateSurgical imaging device electrical component may intermittently shut off
FDA (Devices) · 2024-06-12
- HighO-arm O2 Imaging System Ground Cable Installation Defect Recall
FDA (Devices) · 2023-08-30
- HighMedtronic Recalls O-arm O2 Imaging Systems Due to Belt Loosening
FDA (Devices) · 2020-01-08
- ModerateMedtronic Recalls 0-arm 1000 Imaging Systems Due to Charger Board Defect
FDA (Devices) · 2019-07-10
- ModerateMedtronic Navigation 0-arm 02 Imaging System Software and Hardware Recall
FDA (Devices) · 2018-11-14
Same hazard · software defect
See all →- ModerateBeckman Coulter Recalls DxC 500i Clinical Analyzer Modules Due to Software Error
FDA (Devices) · 2026-10-14
- HighPhilips Spectral CT Systems Recalled for Software Issues Affecting Safety
FDA (Devices) · 2026-10-14
- ModerateSteris HexaVue Focus Integration System Recalled for Patient Data Mismatch
FDA (Devices) · 2026-10-14
- ModerateUnited Imaging uMI 550 PET/CT Systems Recalled for Software Defect
FDA (Devices) · 2026-10-07
- ModeratePhilips SmartPath to MR 7700 Recalled for Incorrect DTI Export Data
FDA (Devices) · 2026-10-07
Similar recalls
- ModerateMedtronic O-arm 1000 X-ray System Software Update Recall
FDA (Devices) · 2018-03-14
- ModerateMedtronic O-arm Imaging System Recalled for Labeling Compliance Gaps
FDA (Devices) · 2014-03-12
- HighMedtronic 0-arm Imaging System Recalled for Navigational Accuracy Issues
FDA (Devices) · 2012-06-27
- ModerateMedtronic Navigation 0-arm 02 Imaging System Software and Hardware Recall
FDA (Devices) · 2018-11-14
- ModerateMedtronic Navigation O-arm 02 surgical x-ray system recalled for labeling gaps
FDA (Devices) · 2016-07-13
- ModerateMedtronic Recalls 0-arm 1000 Imaging Systems Due to Charger Board Defect
FDA (Devices) · 2019-07-10