Medos Velys Robotic-Assist Station Recalled for Software Movement Issue
Medos International Sarl is recalling 29 Velys Robotic-Assist Stations due to a software issue that may cause unintended robotic arm movement during surgery.
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 medical device with a risk of unintended movement during surgery, which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Medos International Sarl is recalling 29 units of the Velys Enabling Tech Robotic-Assist Station (REF: 451611001). The recall is due to a software issue within the robotic controller that may cause unintended movement of the robotic arm during bone preparation or instrument positioning.
The affected devices were distributed nationwide in the United States, specifically in the states of Delaware, Florida, Illinois, Kentucky, Maryland, Michigan, Minnesota, New Jersey, New Mexico, New York, Oregon, Pennsylvania, Tennessee, Texas, Virginia, and Washington. The recall is classified as Class II by the FDA.
Healthcare facilities should contact Medos International Sarl for instructions on how to address the software issue. Patients who have had surgery using these devices should contact their healthcare provider if they have concerns.
The recalled product
- Product
- Velys Enabling Tech Robotic-Assist Station REF: 451611001
- Manufacturer
- Medos International Sarl
- Affected units
- 29
Distribution
Related recalls
Same manufacturer · Medos International Sarl
See all →- SevereVascular guide catheter recalled due to distal end fracture risk
FDA (Devices) · 2024-03-20
Same hazard · unintended movement
See all →- SevereKoenigsegg Recalls CC850 Vehicles Due to Electronic Parking Brake Defect
NHTSA · 2026-10-21
- HighGreenpower Recalls EV Star Buses Due to Software Error
NHTSA · 2026-09-30
- HighATC Recalls 2026 RM500 and RM700 Trailers Due to Winch Remote Issue
NHTSA · 2026-07-22
- HighWarn Industries Recalls Wireless Remote Kits Due to Winch Movement Risk
NHTSA · 2026-07-02
- SevereFord Recalls 2021-2023 Mustang Mach E for Rear Differential Defect
NHTSA · 2026-06-30
Similar recalls
- HighRobotic-Assisted Medical Device Recalled Due to Software Defect
FDA (Devices) · 2022-05-11
- ModerateMedtech Recalls ROSA Robotized Stereotactic Assistant Units for Approval Issues
FDA (Devices) · 2018-06-13
- SevereSenhance Robotic Surgical System uncontrolled arm motion malfunction
FDA (Devices) · 2023-11-08
- HighMedtronic Recalls O-arm 1000 2nd Edition Imaging Systems Due to Software Anomalies
FDA (Devices) · 2018-10-31
- HighMedtronic O-arm Imaging System Recalled for Braking System Failure
FDA (Devices) · 2013-03-20
- HighORION Robotic Arm Recalled for Sudden Acceleration and Collision Risk
FDA (Devices) · 2023-11-29