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.
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: 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.
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