Class 2 Device Recall VELYS" RoboticAssisted Solution Base Station

• Date Initiated by Firm: March 11, 2022
• Create Date: May 02, 2022
• Recall Status: Open, Classified
• Recall Number: Z-1029-2022
• Recall Event ID: 89959
• 510(K)Number: K202769
• Product Classification: Orthopedic stereotaxic instrument - Product Code OLO
• Product: VELYS Robotic-Assisted Solution Base; Product No.: 451570100
• Code Information: Serial Numbers (US): BAS1111 BAS1145 BAS1154 BAS1069 BAS1070 BAS1125 BAS1144 BAS1174 BAS1175 BAS1192 BAS1194 BAS1081 BAS1082 BAS1052 BAS1165 BAS1136 BAS1071 BAS1142 BAS1073 BAS1189 BAS1022 BAS1190 BAS1079 BAS1054 BAS1061 BAS1173 BAS1204 BAS1141 BAS1076 BAS1181 BAS1176 BAS1184 BAS1119 BAS1137 BAS1009 BAS1140 BAS1121 BAS1143 BAS1127 BAS1060 BAS1004 BAS1196 BAS1120 BAS1068 BAS1152 BAS1188 BAS1078 BAS1195 BAS1191 BAS1062 BAS1180 BAS1118 BAS1197 BAS1139 BAS1066 BAS1126 BAS1093 BAS1122 BAS1134 BAS1203 BAS1132 BAS1185 BAS1182 BAS1129 BAS1063 BAS1183 BAS1133 BAS1212 UDI: 10603295519515
• Recalling Firm/ Manufacturer: DePuy Orthopaedics, Inc.; 700 Orthopaedic Dr; Warsaw IN 46582-3994
• For Additional Information Contact: SAME; 574-267-8143
• Manufacturer 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
• FDA Determined 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 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 OneMD-Field-Actions@its.jnj.com 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 velystechsupport@its.jnj.com or via phone at 1-888-228-3597 for additional support to correct this issue.
• Quantity in Commerce: US: 68 units; OUS: 10 units
• Distribution: Worldwide distribution - US Nationwide and the countries of Israel, Australia & New Zealand.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = OLO and Original Applicant = DePuy Ireland UC