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U.S. Department of Health and Human Services

Class 2 Device Recall Sensis recording system

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  Class 2 Device Recall Sensis recording system see related information
Date Initiated by Firm April 13, 2022
Date Posted June 06, 2022
Recall Status1 Open3, Classified
Recall Number Z-1243-2022
Recall Event ID 90175
510(K)Number K150493  
Product Classification Computer, diagnostic, programmable - Product Code DQK
Product Sensis, Programmable Diagnostic Computer, Model Nos. 6623974 6634633
6634658 6648153
6648161 10140973
10764561 10765502
10910620
Code Information UDI-DI: 04056869010137 Material Serial 6623974 40108 6623974 41202 6623974 41017 6623974 42308 6623974 6101 6623974 41021 6623974 6110 6623974 6622 6623974 6727 6634633 3021 6634633 2272 6634633 2563 6634633 2589 6634633 20380 6634633 3112 6634633 2291 6634633 3405 6634633 3406 6634633 3440 6634633 3407 6634633 3408 6634633 3437 6634633 22267 6634633 21334 6634633 3417 6634633 3564 6634633 2060 6634633 2154 6634633 2155 6634633 2201 6634633 3037 6634633 3038 6634633 3041 6634633 3166 6634633 3224 6634633 3226 6634633 3352 6634633 3534 6634633 3536 6634633 20102 6634633 20134 6634633 20137 6634633 20149 6634633 20314 6634633 22688 6634633 2520 6634633 2521 6634633 2506 6634633 2709 6634633 2739 6634633 3072 6634633 21212 6634633 2552 6634633 2744 6634633 3060 6634633 20062 6634633 20574 6634633 2442 6634633 2444 6634633 2500 6634633 2501 6634633 2025 6634633 2276 6634633 2408 6634633 3622 6634633 3650 6634633 3653 6634633 3670 6634633 3671 6634633 3676 6634633 2578 6634633 22427 6634633 20448 6634633 21034 6634633 21035 6634633 21043 6634633 22336 6634633 21037 6634633 21051 6634633 21052 6634633 21095 6634633 21100 6634633 21102 6634633 21438 6634633 22022 6634633 2515 6634633 3390 6634633 2282 6634633 2331 6634633 2332 6634633 20321 6634633 20045 6634633 20047 6634633 3333 6634633 20598 6634633 2203 6634633 3091 6634633 3097 6634633 3059 6634633 3472 6634633 22671 6634633 2434 6634633 20525 6634633 20556 6634633 20557 6634633 2022 6634633 2032 6634633 2629 6634633 20392 6634633 22406 6634633 20594 6634633 20637 6634633 22611 6634633 20162 6634633 22612 6634633 3319 6634633 21399 6634633 22037 6634633 21384 6634633 21395 6634633 21452 6634633 3475 6634633 21332 6634633 22345 6634633 22357 6634633 22366 6634633 2403 6634633 20407 6634633 20033 6634633 22509 6634633 3075 6634633 2225 6634633 20430 6634633 22282 6634633 2113 6634633 2186 6634633 2187 6634633 3049 6634633 3050 6634633 22461 6634633 22462 6634633 22415 6634633 22312 6634633 22663 6634633 22667 6634633 3069 6634633 3128 6634633 3129 6634633 20026 6634633 3316 6634633 22512 6634633 22438 6634633 2608 6634633 3529 6634633 3641 6634633 20538 6634633 21109 6634633 21383 6634633 22341 6634633 2350 6634633 2352 6634633 21297 6634633 22000 6634633 20133 6634633 2205 6634633 2224 6634633 2227 6634633 2229 6634633 21056 6634633 2293 6634633 22628 6634633 22651 6634633 22652 6634633 22670 6634633 20585 6634633 20023 6634633 20399 6634633 20385 6634633 2428 6634633 20561 6634633 22480 6634633 20319 6634633 20618 6634633 22523 6634633 22526 6634633 22528 6634633 22619 6634633 22623 6634633 22627 6634633 22646 6634633 22669 6634633 22681 6634633 22682 6634633 22720 6634633 20139 6634633 22051 6634633 3660 6634633 3101 6634658 8067 6634658 8068 6648153 16001 6648153 16000 6648153 10661 6648153 10883 6648153 16005 6648153 16004 6648153 10700 6648153 10666 6648153 10886 6648153 16100 6648153 10887 6648153 10704 6648153 10723 6648161 11053 6648161 18103 6648161 18104 6648161 11657 6648161 11882 6648161 11251 6648161 18101 6648161 11661 6648161 18105 6648161 18000 6648161 18001 6648161 18002 6648161 11855 6648161 11856 10140973 13240 10140973 13419 10140973 13450 10140973 13215 10140973 13218 10140973 13423 10140973 13272 10140973 13483 10140973 13479 10140973 13243 10140973 13461 10140973 13466 10140973 13467 10140973 13402 10140973 13212 10764561 61297 10764561 60130 10764561 61084 10764561 61108 10764561 60410 10764561 60138 10764561 60412 10764561 60110 10764561 61072 10764561 60147 10764561 60370 10764561 60372 10764561 60125 10764561 60128 10764561 60060 10764561 60116 10764561 60120 10764561 60127 10764561 60129 10764561 60134 10764561 60143 10764561 61083 10764561 61031 10764561 61330 10764561 60079 10764561 61061 10764561 61230 10764561 61232 10764561 61086 10764561 61207 10764561 60369 10764561 60308 10764561 60312 10764561 60040 10764561 61313 10764561 61128 10764561 61133 10764561 61138 10764561 60023 10764561 60024 10764561 60025 10764561 61225 10764561 61310 10764561 61143 10764561 60052 10764561 60468 10764561 60322 10764561 61201 10764561 61224 10764561 60474 10764561 60022 10764561 60089 10764561 61144 10764561 61246 10764561 61088 10764561 60166 10764561 60087 10764561 61241 10764561 60325 10764561 61299 10764561 61302 10764561 61305 10764561 61315 10764561 61309 10764561 61317 10764561 61318 10764561 61239 10764561 61320 10764561 61186 10764561 60062 10764561 61325 10764561 60436 10764561 60444 10764561 60453 10764561 60483 10764561 61064 10764561 61183 10764561 61009 10764561 61169 10764561 60058 10764561 60095 10764561 60311 10764561 61129 10764561 60395 10764561 61281 10764561 61014 10764561 60323 10764561 61008 10764561 61292 10764561 60020 10764561 61136 10764561 61141 10764561 61142 10764561 60359 10764561 61103 10764561 60171 10764561 61121 10764561 61219 10764561 61345 10764561 61198 10764561 60427 10764561 61124 10764561 61403 10764561 61048 10764561 61251 10764561 61253 10764561 61256 10764561 61266 10764561 60473 10764561 61002 10764561 61116 10764561 61394 10764561 61344 10764561 60111 10764561 60123 10764561 61081 10764561 61234 10764561 60347 10764561 60348 10764561 61151 10764561 60355 10764561 60167 10764561 61030 10764561 61089 10764561 60065 10764561 60480 10764561 60154 10764561 61071 10764561 60146 10765502 15134 10765502 15010 10765502 15105 10765502 15111 10765502 15122 10765502 15011 10765502 15121 10765502 15130 10765502 15129 10765502 15143 10765502 15144 10765502 15146 10765502 15001 10765502 15821 10765502 15116 10765502 15108 10765502 15117 10765502 15120 10765502 15112 10765502 15115 10765502 15124 10765502 15125 10765502 15132 10765502 15133 10765502 15013 10765502 15106 10765502 15150 10910620 14326 10910620 14049 10910620 14050 10910620 14058 10910620 14046 10910620 14112 10910620 14113 10910620 14118 10910620 14109 10910620 14014 10910620 14015 10910620 14117 10910620 14119 10910620 14108 10910620 14041 10910620 14308 10910620 14000 10910620 14012 10910620 14127 10910620 14103 10910620 14059 10910620 14304 10910620 14311 10910620 14106 10910620 14325 10910620 14017 10910620 14104 10910620 14004 10910620 14002 10910620 14313 10910620 14121 10910620 14301 10910620 14309 10910620 14305 10910620 14322 10910620 14105 10910620 14315 10910620 14007 10910620 14055 10910620 14110 10910620 14111 10910620 14320 10910620 14302 10910620 14009 10910620 14057 ***Update 8/31/22 - the following units have been removed from the scope of this correction *** 6634633 20314 6634633 20102 6634633 20149 6634633 2506 6634633 2709 6634633 2739 6634633 3072 6634633 21212 6634633 3622 6634633 3670 6634633 3676 6648161 18103 6648161 18104 10764561 61230 10764561 61232 6634633 2434 10764561 61088 10765502 15130 6634633 20594 6634633 20637 6634633 22611 6634633 3319 10765502 15146 10765502 15001 6634633 20033 6634633 22509 10140973 13272 6648161 18105 10764561 61234 6648153 16005 6634633 2203 10764561 60359 6634633 20133 6648153 16001 6648161 11053 10764561 61136 6648161 18101 6634633 21395 10765502 15013 10765502 15106 10910620 14117 10910620 14119 6634633 2442 6634633 2444 6634633 2500 6634633 2501 10764561 61031 6634633 3069 ***Updated 11/9/22 - The following systems have been added to this correction*** 6634633 3136 10140973 13253 ***Updated 1/13/23 - Added the following system*** Material Serial 6623974 42320
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355-1418
For Additional Information Contact Meredith Adams
610-219-4834
Manufacturer Reason
for Recall		 Siemens has become aware of three potential software issues with AXIOM Sensis or Sensis/ Sensis Lite systems. This may lead to a hazardous situation for patients if treatment cannot be continued on the system and treatment needs to be continued on an alternate system.
FDA Determined
Cause 2		 Software Design Change
Action On April 13, 2022, the firm notified customers via an Urgent Medical Device Correction letter. Customers were informed of the software issues. the software in the affected systems will be updated to correct the issue. Siemens' service organization will contact customers to arrange a date to perform the corrective action. Please feel free to contact Siemens' service organization for an earlier appointment at 1-800-888-7436.
Quantity in Commerce 443
Distribution Domestic 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 = DQK and Original Applicant = Siemens Medical Solutions, Inc.
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