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VELYS recallZ-1029-2022 · DePuy Orthopaedics, Inc. · initiated Mar 11, 2022

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from DePuy Orthopaedics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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

FDA root cause category: Software design

What the company is doing

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.

Recall details

Recall number
Z-1029-2022
Status
Terminated
Initiated by the company
Mar 11, 2022
Recalling firm
DePuy Orthopaedics, Inc.
Quantity
US: 68 units; OUS: 10 units
Product code
OLO
FDA submissions
K202769
Distribution
Worldwide distribution - US Nationwide and the countries of Israel, Australia & New Zealand.

Product description

VELYS Robotic-Assisted Solution Base Product No.: 451570100

Code information (models, lots, serial numbers)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Sources and updates

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