Recall Z-1029-2022 · OLO Orthopedic Stereotaxic Instrument
DePuy Orthopaedics, Inc.
VELYS Robotic-Assisted Solution Base Product No.: 451570100
| Date | Mar 11, 2022 |
| Status | Terminated |
| Reason | 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 |
| Root cause | Software design |
| Action | Siemens notified US Consignees contacted via Email/Field Engineers/Sales Reps starting March 11, 2022. Letter Urgent Medical Device Correction states reason for recall, health risk and action to take: The following instructions are to be followed prior to the first use after Daylight Savings Time 2:00 am US Eastern Standard Time, Sunday, March 13, 2022, regardless of local time and observance of Daylight Savings Time. This will synchronize the system clock. 1. Power on the System 2. Wait for the Home screen to appear The following instructions are to be followed prior to the first use after D |
| Quantity | US: 68 units; OUS: 10 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Israel, Australia & New Zealand. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K202769 | VELYS Robotic-Assisted Solution Depuy Ireland UC, Jan 14, 2021 |