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U.S. Department of Health and Human Services

Class 2 Device Recall Ysio Max

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  Class 2 Device Recall Ysio Max see related information
Date Initiated by Firm January 08, 2020
Create Date August 05, 2020
Recall Status1 Open3, Classified
Recall Number Z-2758-2020
Recall Event ID 85999
510(K)Number K133259  
Product Classification System, x-ray, stationary - Product Code KPR
Product SIEMENS Healthineers Ysio Max - Interventional Fluoroscopic X-Ray System, Model: 10762470 - Product Usage: is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image.
Code Information Serial Numbers: 24576 24077 25409 24100 24213 24051 24531 24542 24038 24116 25699 25698 25089 25076 25297 25477 25056 24644 24221 25717 25647 25716 24256 24572 25366 25425 25020 24616 24275 25444 24433 24536 24340 24437 24033 25392 25006 25554 25506 25644 25666 25164 25619 25156 25677 25038 25151 25152 24401 25125 25093 24291 25369 24622 24624 24629 24630 24635 24636 24637 24640 25375 24613 24244 24615 25672 24155 24159 24237 24066 24106 24343 25458 24381 24394 24402 25217 25192 25260 25669 24495 24502 24666 24430 24432 25629 25196 24052 25547 24128 24420 25600 24611 24450 24154 24156 25427 25154 25678 24059 24467 24612 24614 24505 25542 25098 25205 24299 25058 25246 24599 24600 25607 25371 25374 25380 25391 25397 25398 25404 24048 24099 25292 25250 24263 25569 25097 25105 24660 24662 25403 25416 25459 25497 24436 25414 25047 24113 25204 25109 24367 24463 24634 24641 25700 24028 24283 25558 24590 25351 25280 25448 24496 25124 25095 25171 25512 24197 25565 24288 24289 24046 25509 25312 25463 25305 25096 24312 24408 25645 25693 25715 24375 25104 25304 25510 25237 25244 25447 24190 24063 24284 24350 24441 24507 25694 25216 25082 25107 25060 24506 25077 25090 25053 25322 25389 25667 25668 25116 25440 25676 25679 25713 25714 24442 24440 25439 25424 25051 25357 24083 25664 24225 25342 25675 24357 25670 24135 24172 25568 24558 24560 24327 24591 25031 25604 25426 24300 24592 25023 24131 25085 25531 25613 25119 25191 25471 24427 24470 25696 25697 25638 25144 25493 25238 25402 24091 25370 24663 25456 25049 24174 25114 25315 24625 24546 24551 24201 25143 25147 25225 25014 25009 25412 25683 25075 25165 25546 25256 25634 25436 25328 25592 24024 24186 24187 25284 24656 24659 24574 25273 24543 25001 24504 24129 24277 25072 24103 24148 24424 24515 24571 24142 25199 24453 25228 25491 25492 25686 25219 25213 25240 25625 25695 25527 25587 25159 24480 25701 25501 25505 25507 25373 24304 25190 24214 25218 24082 25137 25691 25133 25655 25310 25673 25193 25517 25616 24478 25026 24182 25079 25083 25614 25624 25631 24014 24015 24026 24605 25518 24109 24176 25208 25408 25588 25608 25665 25130 25330 25643 25581 25630 25618 25710 24405 25617 25620 25262 24422 24435 25064 25571 25140 24034 24108 24645 24494 24049 24058 25054 25055 25057 24315 24373 24403 25585 24039 24234 24081 24114 25564 25576 25189 25301 25711 24090 25566 25709 25692 25149 24323 24406 24189 25117 25626 24272 25555 24222 24346 24347 24498 24484 25385 25249 25254 25628 25690 24105 25706 24292 24294 24296 25348 24398 24610 25508 24297 25302 25420 25474 25148 24226 25443 25445 25452 25454 24434 25329 25334 25648 25658 25010 24075 24580 25015 25018 25396 24025 24295 24468 25101 25247 25401 25473 25478 25314 25685 25687 25688 25689 24251 25350 25712 24457 24458 24462 25367 25540 25197 24037 24053 24121 24230 24276 24582 24648 24655 25157 25236 25285 25361 25394 25574 24194 24404 25145 25150 25356 24479 25248 25702 25653 24087 24281 25682 24293 25013 25017 25662 25561 25639 25642 25640 24481 25480 24561 25656 25704 25708 25313 25559 25229 25230 25596 25365 24279 25169 25261 24285 25344 24348 25582 
Recalling Firm/
Manufacturer
Siemens Medical Solutions USA, Inc
40 Liberty Blvd
Malvern PA 19355
For Additional Information Contact SAME
610-219-4834
Manufacturer Reason
for Recall
Two software issues (1) Using the override function in case of blocked system movements affecting Luminos dRF Max, Luminos Agile Max and Uroskop Omnia Max systems may cause collision of the system under operator control with obstacles or persons .(2) Incorrectly assigned image affecting Ysio Max, Luminos dRF Max and Luminos Agile Max systems with detector MAX Static causing incorrect base for diagnosis
FDA Determined
Cause 2
Device Design
Action Siemens Medical Solutions USA, Inc. has initiated a Customer Safety Advisory Notice to all affected customers via XP028/19/S January 2020. Additionally, a solution to eliminate the root cause of this problem is being distributed via XP008/20/S March 2020. Following the corrective action, the cause is eliminated and a recurrence of the fault is prevented. New corrective software VE10Y became available June 22, 2020, and it is being distributed via an Update Instruction XP008/20/S. This update fixes the initial reported issue and the sporadic image loss issue noted by customers who had already installed VE10W (XP029/19/S). The original Customer Safety Advisory Notice (XP028/19/S) and the information letter distributed in March 2020 remain applicable. This resolution will be provided free of charge. Your local Siemens Healthineers Service organization will contact you to arrange a date to perform this corrective action . Questions contact the service organization for an earlier appointment at 1-800-888-7436
Quantity in Commerce 512 units
Distribution US Nationwide distribution.
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 = KPR and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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