Date Initiated by Firm | July 11, 2017 |
Create Date | January 23, 2018 |
Recall Status1 |
Terminated 3 on July 02, 2019 |
Recall Number | Z-0403-2018 |
Recall Event ID |
78830 |
510(K)Number | K060937 |
Product Classification |
System, x-ray, tomography, computed - Product Code JAK
|
Product | Brilliance iCT - Model 728306 Computed Tomography X-ray systems |
Code Information |
Brilliance iCT 4.1.6 version. Brilliance iCT - Model 728306 Codes: 100688 85025 100790 100490 100667 85054 100408 100604 85031 100703 100411 100114 100314 100278 100349 100654 100406 100452 100453 100404 100242 100115 100383 100189 100347 100348 100450 100748 100507 100181 100469 200005 100638 100195 100101 100440 100223 100616 100619 100134 100304 100656 100436 100773 100130 100621 100113 85055 100600 100180 85060 100704 100750 85041 100737 100231 100615 100612 100393 100643 100356 100134 100722 85048 85059 100680 85016 100521 100678 100726 85052 100683 100760 100691 100635 100738 85057 100614 100758 100687 100138 100733 100707 100706 100701 100191 85062 100247 100318 85002 85023 100712 85058 85026 85037 85027 100310 85068 100512 100734 85051 100161 100628 100740 85035 100709 100775 100669 100769 100768 100800 100792 100637 100692 100639 100735 100756 100776 85069 100749 100519 100716 100732 100640 100622 100662 100132 85053 85040 100766 85072 100767 100713 100717 100772 85067 100763 85070 85036 100711 85064 100644 100697 85021 100757 85022 100627 100771 100651 100765 100746 85020 100617 85044 100755 85015 85066 100677 100602 100518 100752 100696 100672 100666 85042 100624 85028 100642 100636 85045 85047 85046 100659 85065 85063 85061 85030 100698 100710 100727 100736 85075 100745 100762 100751 85071 100796 100265 100787 100783 100784 100795 100778 100780 100798 100786 100234 100377 100799 100781 100797 100785 100230 85032 100730 100770 100153 100373 100400 100402 100398 100405 100509 100331 100652 100608 100462 100694 100742 100682 100092 100646 100328 100051 100123 100623 100144 85038 100372 100044 100054 100378 100160 100322 100060 100317 100657 100665 100684 100754 100184 100705 100720 100645 85029 85050 100351 85077 100686 100739 100018 85076 85079 100087 100648 100650 100673 200004 85003 85004 85010 100721 100708 100199 85039 100145 100032 100064 100610 100653 100084 100385 100099 100146 100517 100603 100728 85014 100217 100214 100744 100498 100058 100632 85012 100133 100048 100747 100178 100461 100228 100275 100176 100291 100339 100427 100664 100725 100764 100700 100685 100663 100695 85018 85013 100119 100141 100794 100280 100140 85056 100759 100753 100029 100410 100413 100389 100059 100150 100374 100463 85033 100022 100442 100788 100090 100074 100491 100056 100375 85019 100072 100777 85034 100715 100719 85017 100122 100454 100782 100472 100718 100030 100192 100386 100050 100281 100441 100190 100346 100185 85078 100668 100508 100670 85043 100674 100675 100671 85024 100464 100449 100049 85049 100655 100155 100661 100367 100366 100162 100149 100714 100094 100631 100681 100676 100062 100024 100025 100082 100458 100091 100365 100605 100699 100270 100169 100271 100031 100423 100165 100779 100399 100446 100511 100127 100066 100289 100221 100121 100731 100801 100273 100244 100236 100466 100370 100065 100483 100729 100702 100473 100309 100601 100205 100743 100506 100465 100038 100274 100302 100170 100723 100693 100021 100299 100350 100111 100215 100207 100063 100193 100016 100243 100125 100629 100607 100053 100019 100037 100513 100260 100028 100761 100724 100503 100103 100325 100493 100494 100613 100070 100100 100690 100741 100609 200098 100658 100159 100222 100040 100200 100308 100093 100416 100329 100360 100679 100343 100396 100611 100641 100626 100660 100647 100606 100625 100630 100633 100620 100634 100477 100618 100520 100135 100522 100368 100649 100023 100156 100791 100476 100128 100129 100689 |
Recalling Firm/ Manufacturer |
Philips Medical Systems (Cleveland) Inc 595 Miner Rd Cleveland OH 44143-2131
|
For Additional Information Contact | Ms. Holly Wright Lee 440-483-5777 |
Manufacturer Reason for Recall | Numerous software issues with Brilliance iCT 4.1.6 version. Issues affect scan start position, data acquisition, exam stop, tube overheat, memory overflow, failure to give error message, length of acquisition, image volume and other functions. |
FDA Determined Cause 2 | Software design |
Action | A Customer Information Letter dated June 29, 2017, was sent to US consignees via certified mail. Philips Key Market representatives will distribute the letter internationally, based on local regulations. Additionally, a Field Service Engineer will contact each site to schedule a time to implement the Field Change Order. |
Quantity in Commerce | 559 total |
Distribution | Worldwide distribution, including 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 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 = JAK
|