DePuy Orthopaedics, Inc. recalls VELYS Robotic-Assisted Solution Base Product No.: 451570100
- Recall date
- March 11, 2022
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1029-2022
- FDA classification
- Class II
- Brand / firm
- DePuy Orthopaedics, Inc.
- Sold / distributed
- Worldwide distribution - US Nationwide and the countries of Israel, Australia & New Zealand.
Why it was recalled
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
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
VELYS Robotic-Assisted Solution Base Product No.: 451570100
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