Medtronic Navigation O-arm 02 surgical x-ray system recalled for labeling gaps
Medtronic Navigation is recalling 63 O-arm 02 surgical x-ray imaging systems nationwide due to gaps in electronic product labeling and Instructions for Use compliance.
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 involves a labeling/compliance issue with no reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Medtronic Navigation, Inc. is recalling 63 units of the O-arm 02 surgical x-ray imaging system (model number BT-700-02000) distributed nationwide in the United States. The recall was initiated following an internal management review that identified gaps in compliance with federal requirements for information provided to users, specifically under 21 CFR part 1020.30(h).
The issue involves the on-system electronic product labeling and Instructions for Use. The source text does not report any illnesses, injuries, or deaths associated with this recall. The recall is classified as Class II by the FDA, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Consumers and healthcare facilities should contact Medtronic Navigation for further instructions on how to resolve the labeling compliance issues.
The recalled product
- Product
- Medtronic Navigation O-arm 02 surgical x-ray imaging system
- Manufacturer
- Medtronic Navigation, Inc.-Littleton
- Hazard
- Affected units
- 63
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)
- model number BT-700-02000
Distribution
Distributed nationwide across the United States.
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 · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- ModerateHalyard Laparoscopy Comprehensive Pack II Recalled for Latex Content
FDA (Devices) · 2026-10-14
Similar recalls
- ModerateMedtronic O-arm Imaging System Recalled for Labeling Compliance Gaps
FDA (Devices) · 2014-03-12
- HighMedtronic Recalls O-arm 1000 2nd Edition Imaging Systems for Software Anomalies
FDA (Devices) · 2018-10-31
- ModerateMedtronic Navigation 0-arm 02 Imaging System Software and Hardware Recall
FDA (Devices) · 2018-11-14
- HighMedtronic O-arm O2 Surgical Imaging System Recalled for Calibration Errors
FDA (Devices) · 2016-10-19
- HighMedtronic Recalls O-arm 1000 2nd Edition Imaging Systems Due to Software Anomalies
FDA (Devices) · 2018-10-31
- HighMedtronic 0-arm Imaging System Recalled for Navigational Accuracy Issues
FDA (Devices) · 2012-06-27