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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens Sensis Vibe recording system

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  Class 2 Device Recall Siemens Sensis Vibe recording system see related information
Date Initiated by Firm October 05, 2021
Create Date November 16, 2021
Recall Status1 Open3, Classified
Recall Number Z-0226-2022
Recall Event ID 88870
510(K)Number K150493  
Product Classification Glue, surgical, arteries - Product Code MUQ
Product Sensis/ Sensis Vibe systems with software VD1X as follows: (1)Sensis Model 10764561 (2) Sensis Vibe Hemo Model 11007641 (3)Sensis Vibe Combo Model 11007642 Intended Use: A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies
Code Information Serial Numbers: 15916 15908 103108 103111 15917 103047 103048 103171 103181 103182 103185 103191 103193 103301 103170 103223 103225 103247 15939 103313 103315 100413 100414 100417 100402 14612 14613 101016 101017 101019 101020 101022 101029 101031 101032 101036 18903 15945 15946 103359 15931 100263 103424 15953 103274 15941 15942 103319 103320 103321 103323 103325 103328 103330 103333 103334 103335 103344 100216 103337 15514 15515 100154 100156 100157 14803 14804 18502 15544 15545 100416 102008 103413 15561 101082 101083 101084 18902 14603 100208 100209 102138 103437 15560 101090 102019 102021 102025 102029 15559 101088 15819 15820 102145 102147 103160 15539 100346 100349 103314 102199 15830 102323 102324 102325 15832 15833 103079 122042 123004 15005 15147 100095 100097 100103 100115 100116 100117 100120 100121 102158 102167 102168 102172 122006 122026 102214 102216 102219 102222 102272 101096 102181 102242 102068 102069 102078 102080 102093 102097 15828 15829 102221 103123 103124 103131 100163 100165 15135 15136 100306 100309 15552 15553 101045 101052 101053 101054 101056 101059 101063 101064 103300 15564 15565 101099 101100 101101 15556 15557 101060 101068 101069 101070 101071 101072 103265 14602 100064 15546 14611 100422 14906 103307 103312 103019 10654 11657 14122 14123 103331 103362 103393 103402 103419 103252 103261 103267 103269 103270 103276 103277 103280 103281 103022 100279 103381 15543 15551 100408 100410 100411 100412 101043 102162 122029 103194 103145 103148 103152 15920 15537 15538 100345 123047 15836 15837 102285 102286 102338 102183 15943 15948 103345 103368 103415 103416 123053 15123 103245 103249 103250 103264 15949 15904 103080 103082 103086 103088 103089 103090 15530 100231 103290 15804 102030 102031 102304 101094 18600 15547 15548 101008 101093 15821 15523 100175 100176 102226 101097 15935 15936 103306 103341 15909 102269 102273 102276 102278 102279 103114 14809 14810 102283 15823 15824 102193 15803 15809 15506 15507 100070 100071 100074 102155 102157 15902 15903 103040 103042 14312 103039 15009 102174 102182 15813 15814 103130 103200 103234 103053 14900 103116 103117 103119 103288 18900 18901 14902 15927 15928 14802 15901 103008 103216 102237 103189 103208 15541 100391 15536 102010 15841 15842 102295 102296 102302 18099 100006 18098 14299 100005 10731 15524 15525 100184 15950 103352 122011 102274 14905 103283 15937 15938 103308 103310 15925 15926 103115 103244 103246 103014 15923 15924 103242 101018 121014 15818 102143 102091 Expanded Recall 10/27/21 (36 units) Serial Numbers: 15915 103137 103144 103196 103198 15913 103166 103173 123021 103184 103177 103186 103199 103139 103168 102326 103167 103178 103161 103172 14120 103432 102328 15520 15522 102060 102062 15807 15806 102057 102049 102051 103431 101095 101089 15558
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355-1418
For Additional Information Contact SAME
610-219-4834
Manufacturer Reason
for Recall		 System operator manual states that the system should be rebooted once, every 7 days. In some cases, users are not following these instructions and the system is running for more than 7 days. Under rare circumstances, this may result in a partial freeze of the user interface which would no longer update the vital signs
FDA Determined
Cause 2		 Software design
Action Siemens Medical Solutions USA, Inc. initiated a Customer Safety Advisory Notice to customers via AX067/21/S dated 10/5/21. Letter states reason for recall,health risk and action to take: The software in the affected systems will be updated to display a notification message. Once the system has reached a runtime of more than 7 days, a notification message will be displayed after closing a study to remind the operator to reboot the system as it is running longer than advised. In addition, the system operating manual will include a warning message that the Sensis system can have performance issues when running for more than 7 days nonstop without a restart. A system running nonstop for more than 7 days may display incorrect or delayed vital signs; the values may not be saved, the report generation may be incorrect, and the system could become unavailable before or during an examination. The warning message will also contain the statement that the Sensis system should be restarted at least once a week. Siemens will provide a software update for all affected systems which will be distributed via Update Instruction AX066/21/S. Our service organization will contact you shortly to arrange a date to perform this corrective action. Please feel free to contact our service organization for an earlier appointment at 1-800-888-7436. Please review, understand, and confirm acknowledgement of the information and instructions outlined in this Urgent Safety Advisory Notice. By signing this document, you are acknowledging that you have read and understand the content therein
Quantity in Commerce 403 units
Distribution Nationwide
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 = MUQ and Original Applicant = Siemens Medical Solutions, Inc.
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