Medtronic O-arm Imaging System Recalled for High Voltage Relay Overheating
Medtronic is recalling 17 O-arm Imaging Systems because a high voltage relay fault may cause overheating and burning.
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 is classified as FDA Class II and involves a risk of fire/burn injury from overheating, but the source text does not report any actual injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medtronic Navigation, Inc. is recalling 17 units of the Medtronic O-arm Imaging System. The affected product numbers are BI-700-00027-100, BI-700-00027-100R, BI-700-00027-120, BI-700-00027-120R, BI-700-00027-230, and BI-700-00027-230R. The specific serial numbers affected are 109R, 118R, 124, 136, 159, 170, 218, 222, 223, 236, 239, 299, 309R, 402, 410, 412, and 414.
The recall was initiated because a fault in a high voltage relay within the system might cause the relay to overheat and burn. This is classified as a Class II recall by the U.S. Food and Drug Administration.
The affected units were distributed worldwide, including in the United States (specifically in the states of AL, CO, FL, IA, MI, NC, NE, and NY) and in the countries of South Africa, Italy, and Spain. Users of these devices should contact Medtronic Navigation, Inc. for further instructions regarding the recall.
The recalled product
- Product
- Medtronic O-arm¿ Imaging System. Product Numbers: BI-700-00027-100, BI-700-00027-100R, BI-700-00027-120, BI-700-00027-120R, BI-700-00027-230, BI-700-00027-230R.
- Manufacturer
- Medtronic Navigation, Inc.
- Category
- Medical Device — Imaging System
- Hazard
- Affected units
- 17
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 (17)
- Serial Numbers: 109R
- 118R
- 124
- 136
- 159
- 170
- 218
- 222
- 223
- 236
- 239
- 299
- 309R
- 402
- 410
- 412
- 414.
Distribution
Related recalls
Same manufacturer · Medtronic Navigation, Inc.
See all →- HighMedtronic Percutaneous Reference Pins May Not Fit Properly
FDA (Devices) · 2025-02-05
- HighStealthStation S8 Spine Surgery Navigation System Recalled for Software Defects
FDA (Devices) · 2024-10-16
- SevereStealth S8 neurosurgical navigation software display error affecting surgical guidance
FDA (Devices) · 2024-05-15
- HighMedtronic Percutaneous Surgical Pins Recalled Due to Potential Fitting Defects
FDA (Devices) · 2024-01-17
- HighMedtronic Percutaneous Pins Recalled for Potential Fitting and Removal Issues
FDA (Devices) · 2024-01-17
Same hazard · fire
See all →- SevereVQQQ Gas Patio Heaters Recalled for Fire and Burn Hazards
CPSC · 2026-10-22
- HighAutocar Recalls Xpeditor Trucks for Fuel Hose Separation Risk
NHTSA · 2026-10-21
- SevereAudi Recalls 2024-2025 Q4 E-Tron Models Due to Battery Fire Risk
NHTSA · 2026-10-21
- HighForest River Recalls 2023-2026 Pause Travel Trailers for Wiring Defect
NHTSA · 2026-10-20
- SevereForest River Recalls 2026-2027 Cedar Creek Trailers for Fire Risk
NHTSA · 2026-10-16
Similar recalls
- ModerateMedtronic O-arm Imaging System Recalled for Labeling Compliance Gaps
FDA (Devices) · 2014-03-12
- ModerateMedtronic Navigation O-arm 02 surgical x-ray system recalled for labeling gaps
FDA (Devices) · 2016-07-13
- HighMedtronic Recalls O-arm O2 Imaging Systems Due to Belt Loosening
FDA (Devices) · 2020-01-08
- HighMedtronic O-arm Imaging System Recalled for Braking System Failure
FDA (Devices) · 2013-03-20
- HighMedtronic 0-arm Imaging mobile x-ray system recall for battery damage risk
FDA (Devices) · 2016-07-13
- HighMedtronic Recalls O-arm 1000 2nd Edition Imaging Systems Due to Software Anomalies
FDA (Devices) · 2018-10-31