Date Initiated by Firm | June 30, 2015 |
Date Posted | August 18, 2015 |
Recall Status1 |
Terminated 3 on December 05, 2016 |
Recall Number | Z-2404-2015 |
Recall Event ID |
71762 |
510(K)Number | K123529 |
Product Classification |
Interventional fluoroscopic x-ray system - Product Code OWB
|
Product | Artis zee/ zeego systems; dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. |
Code Information |
Model Numbers of device: 10094135, 10094137, 10094139, 10094141, 10094142, 10094143, 10280959 with serial numbers: 146669 153131 153229 146877 157435 146663 147100 147049 147233 136077 147189 147190 153695 157660 153727 157458 146335 146659 153779 146993 153280 153648 153674 160395 160484 135757 136513 136562 147273 157698 147030 147239 146988 160348 157532 160502 146899 135102 153169 146643 136042 153803 146361 146365 146366 146369 146116 146164 146168 153110 160392 147371 160115 135986 157690 154074 154012 147129 135841 153732 147210 160449 153274 157710 160463 146235 147267 153227 154090 153655 157677 153234 153285 157528 146741 147047 157503 154095 153328 146195 146113 146187 146189 146636 147042 157615 153106 153916 160134 160136 146630 146766 146154 146298 154086 135235 147208 147247 147096 160347 147236 140101 140205 147175 157700 153139 160506 136568 153211 147023 146851 147249 147255 160488 135779 136224 146355 147105 147304 157213 160455 136109 146334 160435 136607 136579 154098 154073 146888 147172 154076 160451 136280 136286 147164 146324 147357 147363 147365 135413 147378 154156 146357 146619 153351 135144 135145 136362 153112 153155 146856 146921 157750 135404 157579 146724 140209 136318 153857 147035 160493 153226 147193 147196 157671 146323 146812 157554 157555 146241 146242 146635 147025 157713 157521 153190 136234 146251 160391 146727 146238 146388 160470 147203 136500 147098 136515 147113 160447 160471 135124 135125 136084 147107 153125 153128 153134 153135 160481 157696 136479 147121 135179 160403 160404 146612 157488 153829 157644 157648 140219 160008 146846 136384 136387 136488 153217 135770 153639 153119 136550 147243 160438 136005 136063 146709 153164 153304 136256 135767 136408 136450 136508 136547 147124 160388 147144 147237 147240 153869 136242 136383 146935 157169 153357 147268 146798 157508 157510 153770 147168 154020 136517 160346 146353 136043 146706 160384 157588 146205 157601 153929 153930 136586 147285 146722 153728 140218 154058 136393 153225 160114 157139 160450 154155 153875 146690 146691 153884 136520 146987 153289 157536 153664 153963 160149 146424 146983 157625 140204 154034 136548 154018 140221 146279 146289 146750 157600 157604 160387 147296 147171 146184 160446 160394 157565 135114 135133 157634 157635 146969 146973 147200 136350 153113 135353 135253 157146 157583 153235 153347 149100 147067 154066 135772 147059 147177 136483 136555 146784 157476 157497 135122 147238 146887 160432 153259 153314 154014 147241 146210 136614 136567 146170 146220 146919 146257 147009 147114 153716 147214 147216 146963 147373 160483 147123 146895 146909 157570 153870 160402 153107 146130 153628 146939 146696 146103 146104 153819 160148 154087 136254 146313 160460 160485 146147 146759 160443 147155 153156 146735 160370 146991 146857 135109 153147 160381 136561 135302 140226 153928 136505 160412 146652 154052 147093 147264 146869 135182 154028 160122 135868 154084 147079 157674 160407 146960 147027 153865 146994 146370 146372 146373 146982 153161 146386 146340 135723 146217 149106 147287 157414 153657 136126 146339 146341 160494 147106 160501 146234 153757 136217 135847 153117 154064 160390 147205 147250 147251 147252 147253 147254 160507 160487 136557 136558 160418 157668 160007 136391 136503 154035 154056 153999 153124 146933 146348 146925 146929 153120 153122 160508 135388 153329 153366 149101 157692 160486 154100 153327 147372 140108 153818 154007 160430 160482 147157 136582 140102 154055 136570 146287 146941 146632 147207 154067 154088 160462 160520 135954 153762 136459 147234 157707 160505 146883 146297 157708 136518 146915 154094 160474 147295 153265 140109 160116 160428 157659 157661 146326 153141 153195 140100 146644 153920 136290 140202 146944 153343 157688 160357 160369 160498 146821 146833 140214 136609 135233 157409 153631 136594 146285 146337 146398 146427 146677 147307 153354 153684 153799 154041 160128 160413 160414 146976 146705 147303 157702 153742 153952 154077 160373 160509 153214 147265 157704 153722 135203 153206 147235 160551 147094 140114 153255 154097 146211 153115 136137 146698 157442 135286 146977 146928 140212 135944 147109 146122 136278 160477 157667 146955 135111 135112 146166 146140 147186 |
Recalling Firm/ Manufacturer |
Siemens Medical Solutions USA, Inc 51 Valley Stream Pkwy Malvern PA 19355-1406
|
For Additional Information Contact | Customer Support 610-219-6300 |
Manufacturer Reason for Recall | in case a system error occurs and the system enters the "Bypass Fluoro" mode while the X-ray locking function is active, the only way to exit the X-ray locking function, would be to either resolve the root cause of the system being in "Bypass Fluoro" or to restart the system.
|
FDA Determined Cause 2 | Software design |
Action | A customer advisory notice, dated June 30, 2015, was sent to consignees informing them of the corrective action that would be performed to prevent the possible loss of the image generation function. Siemens plans to contact end users to install a software patch. For questions regarding this recall call 610-219-6300. |
Quantity in Commerce | 586 |
Distribution | 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database | 510(K)s with Product Code = OWB
|