Class 2 Device Recall Philips OmniDiagnost Eleva

• Date Initiated by Firm: May 01, 2018
• Date Posted: June 27, 2018
• Recall Status: Terminated on June 08, 2020
• Recall Number: Z-2300-2018
• Recall Event ID: 80271
• 510(K)Number: K032046
• Product Classification: System, x-ray, fluoroscopic, image-intensified - Product Code JAA
• Product: OmniDiagnost-Eleva X-ray system Angiographic and Diagnostic, Product Nos. 708026, 708027, 708028
• Code Information: As-Maintained System Equipment Number: 506241 500046 521648 522220 520020 533314 533471 533530 535257 535118 535924 540860 539106 547017 547142 547348 550258 553235 556585 558404 553676 41446090 42036161 42383151 43180366 43680651 43721258 41444692 41445222 44650754 41445407 533112 541490 41955077 529685 529691 529684 529698 531893 529697 535941 529696 539264 546436 545873 539037 546528 546466 546455 545730 545598 539038 552988 551489 41455862 41444624 42065190 16846483 32253458 34036766 34179085 34968065 38562442 35122350 35127482 35016455 35145439 35112843 37601105 36664230 39524825 41681475 41827402 16724453 17005034 30533360 31497860 32026120 32205530 31595070 33426990 34135240 34819721 34819433 38632412 49595524 39740578 31605917 32310045 32008570 31954213 32749341 33426349 32865331 33827811 33827815 34087855 34087725 34079339 34793296 35569101 37097710 38745116 42863234 45071255 31595927 31555908 31596387 32413391 32677737 35412750 47712544 36699008 36875502 48055521 48392876 47996476 47839619 48393084 47880448 48063679 48043493 48042722 47987365 48025752 47928350 47892427 48061968 48042349 47856992 48061077 47844521 47926256 47839510 47877204 48040901 47962639 47947771 47896920 47897948 47955020 47923399 47847457 48050932 47987662 48018973 47875559 48045859 48004328 48047339 47961100 48019288 47851789 47844718 47912804 47998626 47887154 47996779 48000293 47871220 47871127 47933015 47893201 47840174 47852334 47867843 47895480 47965379 47920668 47934675 48061768 48334268 48049352 47865582 48063783 48029479 48029389 48005570 47846129 48043619 48023634 47837558 48174545 47958286 48040455 100026747 100033278 100041586 100041603 100061466 100063646 100084933 100093452 100093436 100102230 100109716 33402044 34233967 34463532 34987357 35189871 36843853 38744050 38328053 38743946 41690350 41399001 42570682 47799271 36214396 64514623 48157631 57418995 51110146 51110037 50887154 51092653 51025290 50908284 50885339 51110174 51030160 51025580 50970665 50961004 50970143 51095401 51024984 51080305 51080435 50914508 50962780 51022063 50981343 51086558 50897103 50891138 51012770 51014415 51081688 51038516 51014529 51105516 51059680 50969778 50958349 50907680 50950144 50985141 51013728 51020210 51020502 51064326 51001594 51019345 51021040 50972379 51104190 51074083 51003697 51100065 51099787 50951862 51017657 51033813 51085681 51038959 50989026 51104722 50986156 50983815 51099679 50974806 51053320 50983488 51095683 50963733 50963594 50488184 50488540 51002851 50959349 51054362 51100399 51086078 50972966 51018182 31555798 31555688 38928845 42093747 42093748 42093749 30194246 32205774 33427817 33427706 43675063 31555525 31555354 32771972 33722859 49323885 31272978 41698508 43702334 44287572 44287569 49483669 48153095 47986279 47985530 42680936 19656139 30338356 32809246 32820380 33367274 42680678 39073021 44212760 45103235 47334370 47422321 48684938 34486707 34860779 34860915 50271759 18786524 19122290 30526507 31179916 43683626 35772065 17635851 31420757 66601206 33295942 35876171 53595739 53595734 53595733 53595737 53595756 53595732 53595743 53595741 53595738 53595742 40278943 36382702 36975163 100128414 39102671 38629491 38024841 18916727 48113308 48156134 31597580 57754851 57758645 57729632 39282417 38928696 43054708 39628723 31422052 32054216 34860550 35923960 39275070 39403263 33723699 18814694 19102005 19102185 34192232 35782559 35469253 36167580 37199210 37148157 37259300 37145447 37151691 37160876 37195241 37150933 37204968 37217176 37216367 37258000 37152918 37164994 37244727 37151900 37161919 37254326 37185669 37141202 37253217 37168260 37198948 37178216 37199515 37179321 37198579 37229436 37156822 37152189 37200918 37229759 37180245 37181737 37169355 37155899 37264479 37201221 37169665 37169665 37500358 37499453 38034826 39049919 41753759 42607120 47806697 44498445 49324557 30339366 45417510 30268903 30268672 34815116 34768065 34763050 34755318 34768201 34758089 36797049 41619825 44817537 36733006 39176289 43545373 30348538 44152040 43176025 43176026 43441363 31372148 32678129 34473724 31373432 39200433 43842394 36407674 36408979 36417982 36224105 38040268 43451536 43451537 44604719
• Recalling Firm/ Manufacturer: Philips Medical Systems Nederlands; Veenpluis 4-6; Best Netherlands
• Manufacturer Reason for Recall: The fixation of the upper and lower tilt actuator, of the Omnidiagnost system might break off and the table will start to rotate from 0 to + 90 /- 90 degree with high speed. This rotating movement can not be stopped by the user. This could potentially lead to the patient falling off the table. There is a risk of injury for the patient, user, or bystander.
• FDA Determined Cause: Device Design
• Action: On May 17, 2018, the firm issued Urgent Medical Device Correction letters to affected consignees. Customers were advised of the product issue. Customers were instructed to do the following: Stop using the system and call your Philips representative if any of the following situations occurs: . the table height or tilt movement is not working. . you notice a cracking sound or snapping sound different than the normal sound during height or tilt movement. . you experience a blockade in the table height or tilt movement during system movements. . the system is having an unexpected collision or the system had an unexpected collision in the past 2 months. . you have used a CPR stand that obstructed the system, or . you notice any (other) unusual system behavior beyond the normal use of the system. Avoid collisions with the table and base stand of the system by ensuring that no obstacles are placed around the system. Customer shall ensure that all staff with access to the affected systems are informed of the content of this Field Safety Notice. A copy of this Field Safety Notice shall be placed together with the documentation of the system until the system has been corrected by Philips. The firm plans to correct all potentially affected products in the field by means of a field change order free of charge. Customers will be contacted by a local Philips representative to schedule the corrective action, which will start effective July 2018. Customer with further questions may contact Philips Technical Support Line: 1-800-722-9377.
• Quantity in Commerce: 508
• 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 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 = JAA and Original Applicant = PHILIPS MEDICAL SYSTEMS, INC.