FDA-Device2022-05-11Class II
VELYS Robotic-Assisted Solution Base Product No.: 451570100
DePuy Orthopaedics, Inc.
Hazard
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
Sold states
Worldwide distribution - US Nationwide and the countries of Israel, Australia & New Zealand.
Affected count
US: 68 units; OUS: 10 units
Manufactured in
700 Orthopaedic Dr, N/A, Warsaw, IN, United States
Products
VELYS Robotic-Assisted Solution Base Product No.: 451570100
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1029-2022Don't want to check this manually?
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