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U.S. Department of Health and Human Services

Class 3 Device Recall Siemens

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  Class 3 Device Recall Siemens see related information
Date Initiated by Firm July 12, 2022
Create Date August 18, 2022
Recall Status1 Open3, Classified
Recall Number Z-1558-2022
Recall Event ID 90632
510(K)Number K150493  
Product Classification Computer, diagnostic, programmable - Product Code DQK
Product AXIOM Sensis or Sensis Vibe Combo systems as follows:
System Material #
AXIOM Sensis, Combo 64 6623974;
AXIOM Sensis, Hemo LOW 6634633;
AXIOM Sensis, Combo 32 6634641;
AXIOM Sensis, EP 129 6634658;
Sensis 10764561;
Sensis Vibe Combo 11007642;

Sensis recording system is intended to be used as a diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as interventional Radiology.
Code Information 1.Sensis 10764561  UDI-DI:04056869010137 2. Sensis Vibe Combo 11007642  UDI-DI: 04056869010205  Serial Numbers: 2022 2025 2032 2060 2113 2139 2154 2155 2186 2187 2201 2205 2224 2225 2227 2229 2269 2272 2276 2282 2291 2293 2294 2331 2332 2349 2350 2352 2403 2408 2425 2428 2442 2444 2500 2501 2515 2520 2521 2532 2552 2563 2576 2578 2581 2589 2608 2629 2744 3014 3015 3021 3037 3038 3041 3049 3050 3051 3057 3059 3060 3069 3075 3091 3097 3101 3103 3112 3128 3129 3134 3136 3140 3142 3166 3205 3206 3224 3226 3316 3321 3333 3352 3383 3390 3405 3406 3407 3408 3417 3432 3434 3437 3440 3464 3472 3475 3529 3534 3536 3564 3641 3642 3650 3653 3655 3660 3671 3676 4003 6101 6103 6110 6208 6622 6625 6631 6702 6727 8067 8068 20004 20015 20016 20023 20026 20045 20047 20048 20056 20062 20065 20109 20127 20139 20161 20162 20319 20321 20380 20383 20385 20391 20392 20399 20407 20430 20448 20466 20525 20538 20546 20556 20557 20561 20573 20574 20575 20585 20598 20606 20618 20622 20660 21000 21034 21035 21037 21043 21051 21052 21056 21074 21076 21077 21095 21096 21098 21100 21102 21106 21109 21112 21226 21244 21297 21332 21334 21345 21346 21363 21383 21384 21388 21391 21399 21438 21452 21498 22000 22022 22037 22051 22217 22249 22251 22252 22267 22282 22312 22336 22341 22345 22357 22366 22406 22415 22423 22427 22436 22437 22438 22461 22462 22474 22480 22490 22512 22522 22523 22526 22528 22605 22612 22619 22623 22627 22628 22646 22648 22651 22652 22663 22667 22669 22670 22671 22681 22682 22688 22708 22720 40011 40012 40108 41017 41019 41021 41202 42109 42209 42308 60020 60022 60023 60024 60025 60040 60052 60058 60060 60062 60065 60079 60087 60089 60095 60110 60111 60116 60120 60123 60125 60127 60128 60129 60130 60134 60138 60143 60146 60147 60154 60166 60167 60171 60308 60311 60312 60322 60323 60325 60347 60348 60355 60369 60370 60372 60395 60410 60412 60427 60436 60444 60453 60468 60473 60474 60480 60483 61002 61008 61009 61014 61030 61031 61048 61061 61064 61071 61072 61081 61083 61084 61086 61089 61103 61108 61116 61121 61124 61128 61129 61133 61138 61141 61142 61143 61144 61151 61169 61183 61186 61198 61201 61207 61219 61224 61225 61239 61241 61246 61251 61253 61256 61266 61281 61292 61297 61299 61302 61305 61309 61310 61313 61315 61317 61318 61320 61325 61330 61331 61344 61345 61394 61403 121014 122006 122011 122026 122029 122042 123004 123021 123047 123053 123055 123056 123058 
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		 The Sensis Signal Input Box provides hooks as a milled item on the bottom of the box support the possibility of mounting the Signal Input Box on an accessory rail (e.g., at the patient table), In the event the mounting position deviates from the default position, the following are possible: Patient touching the Signal Input Box may result in a touch leakage current to the patient; Spillage of liquid entering the Signal Input Box
FDA Determined
Cause 2		 Device Design
Action Siemens Healthineers issued Urgent Medical Device Correction letter dated 7/12/22 to US consignees. The letter states the reason for recall, health risk and action to take: Please follow the instructions in the attached addendum which are a supplement to the Operator Manual chapter "Positioning the signal input box". Siemens has updated the affected documentation and is distributing an Addendum to the Operator Manual to all affected customers via Update Instruction AX033/21/S. Please file this Customer Safety Advisory Notice and Addendum to the Operator Manual with all system documentation. Following the correction, the cause is eliminated, and any recurrence of this potential fault is prevented.
Quantity in Commerce 399 units U.S.
Distribution US Nationwide Distribution Foreign: Albania Algeria Angola Argentina Armenia Aruba Australia Austria Azerbaijan Bahrain Bangladesh Belgium Bolivia Bosnia and Herzegovina Brunei Darussalam Bulgaria Cambodia Cameroon Canada Chile China Colombia Costa Rica Croatia Cuba Cyprus Czech Republic Denmark Ecuador Egypt El Salvador Estonia Ethiopia Finland France Georgia Germany Ghana Greece Guatemala Hong Kong Hungary India Indonesia Iran Iraq Ireland Israel Italy Japan Jordan Kazakhstan Kenya Kosovo Kuwait Latvia Lebanon Libya Luxembourg Macao Malaysia Maldives Mali Mauritius Mexico Moldova Montenegro Morocco Mozambique Myanmar Namibia Netherlands New Caledonia New Zealand Nigeria North Korea Norway Oman Pakistan Palestine, State of Panama Paraguay Peru Philippines Poland Portugal Qatar Romania Rwanda Saudi Arabia Serbia Singapore Slovakia Slovenia South Africa South Korea Spain Sri Lanka Sudan Suriname Sweden Switzerland Syria Taiwan Tajikistan Tanzania Thailand Trinidad and Tobago Tunisia Turkey Turkmenistan Uganda Ukraine United Arab Emirates United Kingdom Uruguay Uzbekistan Venezuela, Bolivarian Republic of Vietnam Yemen
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 = DQK and Original Applicant = Siemens Medical Solutions, Inc.
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