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Class 2 Device Recall VELYS" RoboticAssisted Solution Base Station |
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Date Initiated by Firm |
March 11, 2022 |
Create Date |
May 02, 2022 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-1029-2022 |
Recall Event ID |
89959 |
510(K)Number |
K202769
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Product Classification |
Orthopedic stereotaxic instrument - Product Code OLO
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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
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For Additional Information Contact |
SAME 574-267-8143
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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
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FDA Determined Cause 2 |
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
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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.
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510(K) Database |
510(K)s with Product Code = OLO and Original Applicant = DePuy Ireland UC
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