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Recall

VELYS Robotic-Assisted Solution Base Product No.: 451570100

DePuy Orthopaedics, Inc. · 11 March 2022

Status
Recall terminated
Why, in the FDA's words
“System software v1.5.1 has a system software issue related to the Daylight Savings Time (DST) change that can cause a system error, requiring the user to restart the system and potentially cause a delay in treatment”
Recall began
11 March 2022
Company
DePuy Orthopaedics, Inc.
Device type
Orthopedic stereotaxic instruments (knee, hip and spine robots) (OLO)
Concerns
K202769

What it means

A recall is the FDA's record that a company is correcting or removing a device because of a problem. Many are fixed with a software update or new instructions; the record does not say whether anyone was hurt. See our plain guide to FDA terms.

The record

The FDA publishes this record in its public device database. The summary documents the company filed, when available, are linked from the FDA's page.
FDA database