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Terminated

VELYS Robotic-Assisted Solution Base Product No.: 451570100

FDA Recall Z-1029-2022 · Posted None

Recall StatusTerminated
Product CodeOLO
Date Initiated2022-03-11
Date Terminated2024-04-18
Product QuantityUS: 68 units; OUS: 10 units

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

Firm 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 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. Once this notification is received, please complete, sign, and return the attached Business Response Form (page 3 of this letter) to [email protected] within 3 business days of receipt of this notification. Please include in the email subject: FA 2090694: 2022 VELYS" Station SW DST Issue. " Forward this notice to anyone in your facility that needs to be informed (i.e., those who manage, transport, store, stock, or use the subject products). " Contact your VELYS" Technical Support Team through email at [email protected] or via phone at 1-888-228-3597 for additional support to correct this issue.

Root Cause

Software design

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Israel, Australia & New Zealand.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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