Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Artis zee ceiling

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Artis zee ceiling see related information
Date Initiated by Firm February 23, 2022
Date Posted April 21, 2022
Recall Status1 Open3, Classified
Recall Number Z-0968-2022
Recall Event ID 89860
510(K)Number K181407  
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
Product Artis zee ceiling, Model Number 10094137
Code Information UDI: 4056869010052; Serial Numbers: 146669 146877 146996 146663 147100 146286 146292 146410 146676 148281 148299 147155 147678 146406 146407 146411 146166 147762 146121 147885 146710 125115 125276 125262 146945 125253 125213 125238 125245 147189 147190 146679 150011 146766 148429 125265 146232 147573 148454 147996 146408 146409 146728 148498 147889 146335 148404 146659 148499 148235 147909 147833 147847 147888 146898 148402 148333 150002 147273 125105 125106 147761 146814 146871 147783 147891 147581 147857 147882 146899 146368 146643 125100 147608 147983 146650 146361 146365 146366 146369 146912 146116 146164 146168 150017 147604 147079 125216 125202 125209 147371 146156 146343 148401 148486 148487 148488 148485 147899 147129 146260 146277 125013 147760 147923 147636 147081 146235 148423 146868 148422 148509 146758 146818 146741 146174 125255 147507 147047 147667 147679 148348 147685 125011 125111 147803 146173 146176 146186 146187 146189 146630 147630 146266 125249 125281 125286 125278 146305 146908 125241 148349 148384 146267 146219 146272 146274 147096 125022 147912 148260 148335 148390 146298 147982 146637 125268 147841 147078 146327 146333 146338 147786 148465 147924 147023 148220 125211 147910 148288 147919 147921 125021 148463 148490 146851 147514 147954 146688 147918 148393 148513 146144 148250 125256 147188 146324 147925 147926 147928 147558 146715 146293 125267 125269 146308 147105 147955 147956 147957 147958 148001 146825 146827 146828 147304 148277 146937 147024 146946 146334 125222 125700 125005 147953 146322 146888 147585 147553 125230 146732 146857 147736 148027 147645 148215 148216 147906 146738 146795 147164 147974 148408 125226 148298 125118 125705 148025 147087 146742 146169 125204 147972 148426 148030 125260 148351 147992 146921 146263 146781 147938 148282 146721 146724 146860 146393 148481 148411 148418 125024 147035 125009 147196 146323 146150 146812 146635 147583 146354 147852 147025 146251 146238 146388 148503 146382 125113 146755 146756 147203 125274 146119 146264 146618 147894 148010 148439 147675 147905 146139 146656 147516 125229 147107 147249 147255 147700 146942 146886 147167 147702 147935 148543 148516 147500 147121 147969 148270 125243 147936 150005 147898 147106 146731 147850 147681 147795 146394 147845 146846 146855 148446 147652 147773 125019 147243 146918 148014 148019 147827 146709 147789 147877 147878 147541 148400 147831 147124 147893 146901 147144 147237 147240 146623 146634 125223 146863 146934 146935 147577 147896 146806 147268 146798 147168 147587 148268 148358 146619 146205 146803 147285 147612 146722 146774 147880 148407 148409 148442 146712 146740 148022 147625 147635 146690 146691 147036 125263 146786 148023 146424 148011 146152 146975 146279 146289 147296 147171 146184 125231 147695 125273 125251 125285 125240 146775 146776 146969 147200 147733 125109 125235 147067 125016 146750 125208 125239 146872 146784 146397 148443 146887 147692 147693 148285 147241 146711 146233 147644 147666 147701 147009 147648 146170 146220 146919 147821 150023 146183 148479 125275 146839 146178 147214 147866 146963 147373 147123 146212 146895 146909 146627 146713 146320 147668 148478 146175 146179 146181 147673 146861 148493 148352 146939 146696 125257 147800 146104 146948 146964 146729 148254 148318 146313 125205 125119 146158 146959 148243 148431 146147 125210 147561 125017 147939 148397 125117 125116 148392 148512 146779 146735 147665 146991 147944 148474 147867 146759 147871 147813 125219 125212 146748 148278 148326 146652 146631 146905 146111 146161 147988 150009 146830 147649 146123 147093 147264 147364 146197 147075 146136 147775 147790 146869 125201 125233 147839 147862 147655 147900 148316 148273 146761 147175 125023 146896 150015 148341 125214 148307 148420 147027 146701 146703 146720 146747 148020 146370 146372 146373 147620 147715 146386 146340 146217 147287 125227 125228 148207 147977 147881 147633 148444 148029 147621 146667 125008 147250 147251 147252 147253 147254 148363 148437 146239 147676 147717 147778 148445 147952 148230 148469 148470 146348 147931 147933 148449 146697 146925 146929 148236 147927 146801 146719 147643 148021 146138 147363 146692 146694 125232 148484 148466 147892 146206 146391 146658 146357 147662 146811 146632 146927 147646 146821 146833 147670 125015 148440 146883 146297 146352 146290 146915 148258 146287 146326 147557 146245 147661 146398 147766 148375 147971 148224 148327 146427 148225 147917 146677 147307 148489 146705 147842 147303 148274 147849 147265 147301 148263 146881 146733 147739 147743 147752 125280 125244 148514 148522 150003 146714 146107 148525 147937 146700 147746 147528 147656 125250 125254 146118 146149 146299 146698 147940 146817 146797 146782 147687 146928 148239 148240 148242 148432 147109 148245 125270 148526 146140 146866 146867 147863 147186 Additional Serial Numbers as of 10/4/23: 146257 147046 146976 147030 146242 147815 147174 147216 147749 147172 147119 148491 147103 147372 125002 147094 147515 146780 146960 147157 147552 147165 146829 147657 147235 147210
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		 If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display the message "TUBE HOT, have a break". Several minutes later the system will block X-ray to prevent further damage and display the message "NO XRAY: TUBE TOO HOT".
FDA Determined
Cause 2		 Device Design
Action An URGENT: MEDICAL DEVICE CORRECTION notification letter dated 2/23/22 was sent to customers. Which steps have to be taken by the user to avoid the possible risks associated with this problem? As also described in the Operator Manual, we recommend that the system operator checks the water level of the cooling circuit at least every three months and refills water, if necessary: 1. Open the filling gland of the cooling unit. The water surface must be clearly visible above the cooling ribs. 2. Replenish with water (drinking water quality) if cooling liquid is lacking. Please inform the service technician in case of lacking cooling liquid. How will the corrective action be implemented and what is the efficiency of the corrective actions? The tube cooling unit will be equipped with a water level sensor and the software will be updated accordingly. In case the coolant level drops below a certain threshold the following message will be displayed: Tube cooling water level low: Refill as per Operator Manual . Siemens will correct the error with a hardware and software update via Update Instruction AX002/20/S and AX004/20/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. We do not consider it necessary to re-examine any patients in relation to the issues described above. Following the correction, the cause is eliminated, and any recurrence of this potential fault is prevented. Acknowledge Receipt of this Safety Advisory Notice 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. If you have received this notification by email via Adobe EchoSign, kindly sign with your digital signature to acknowledge that you have read and understand t
Quantity in Commerce 709 systems
Distribution US 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 = OWB and Original Applicant = Siemens Medical Solution USA, Inc.
-
-