Robotic-Assisted Medical Device Recalled Due to Software Defect
The FDA is recalling the VELYS Robotic-Assisted Solution Base due to a software defect in version 1.5.1 related to Daylight Saving Time changes. The defect can cause system errors requiring restart, potentially delaying patient treatment.
What this means for you
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: FDA Class II medical device with a software defect that poses a risk of harm in a treatment context. While no injuries have been reported, the potential for delayed treatment creates a clear risk of patient harm.
Plain-English summary
The FDA is recalling the VELYS Robotic-Assisted Solution Base (Product No. 451570100), manufactured by DePuy Orthopaedics, Inc. This is a Class II medical device.
The recall is due to a software defect in version 1.5.1 related to Daylight Saving Time changes. This defect can cause a system error requiring the system to be restarted, potentially causing delays in patient treatment.
Approximately 68 units have been distributed in the United States, with 10 additional units distributed in Israel, Australia, and New Zealand. Affected devices can be identified by specific serial numbers listed in the FDA recall notice.
The recalled product
- Product
- VELYS Robotic-Assisted Solution Base Product No.: 451570100
- Manufacturer
- DePuy Orthopaedics, Inc.
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · DePuy Orthopaedics, Inc.
See all →- HighATTUNE AFFIXIUM Knee Implant Component Recalled for Incorrect Labeling
FDA (Devices) · 2024-04-10
- HighAttune Revision Limb Preservation System Tibial Insert Recalled for Over-Irradiation
FDA (Devices) · 2023-03-29
- HighDePuy Attune Tibial Insert Recalled for Excessive Radiation Exposure
FDA (Devices) · 2023-03-29
- HighOrthopedic Implant Recall: Excessive Radiation Exposure in Revision Tibial Insert
FDA (Devices) · 2023-03-29
- HighOrthopedic Tibial Insert Recalled Due to Excessive Radiation Exposure
FDA (Devices) · 2023-03-29
Same hazard · software defect
See all →- HighMidmark IQecg Digital ECG Software Recall for Inaccurate Waveforms
FDA (Devices) · 2026-09-02
- HighMidmark Digital ECG Software Recall for Incorrect Waveform Display
FDA (Devices) · 2026-09-02
- ModerateEndoFLIP System Recall Due to Incorrect Catheter Expiration Flags
FDA (Devices) · 2026-08-26
- HighBeckman Coulter DxC 500i Analyzer Modules Recalled for Software Defect
FDA (Devices) · 2026-08-26
- HighMitsubishi Recalls Outlander Models for Rearview Camera Software Defect
NHTSA · 2026-08-25