VELYS Robotic-Assisted Solution Base Product No.: 451570100
Reported: May 11, 2022 Initiated: March 11, 2022 #Z-1029-2022
Product Description
VELYS Robotic-Assisted Solution Base Product No.: 451570100
Reason for Recall
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
Details
- Recalling Firm
- DePuy Orthopaedics, Inc.
- Units Affected
- US: 68 units; OUS: 10 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Israel, Australia & New Zealand.
- Location
- Warsaw, IN
Frequently Asked Questions
What product was recalled? ▼
VELYS Robotic-Assisted Solution Base Product No.: 451570100. Recalled by DePuy Orthopaedics, Inc.. Units affected: US: 68 units; OUS: 10 units.
Why was this product 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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 11, 2022. Severity: Moderate. Recall number: Z-1029-2022.
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