• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Extended Brilliance WorkstationNM (EBWNM)

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


New Search Back to Search Results
 Class 2 Recall
Extended Brilliance WorkstationNM (EBWNM)
see related information
Date Posted November 10, 2011
Recall Status1 Terminated on January 30, 2013
Recall Number Z-0182-2012
Recall Event ID 60036
Premarket Notification
510(K) Numbers
K012009  K080961 
Product Classification System, Image Processing, Radiological - Product Code LLZ
Product Extended Brilliance Workstation-NM (EBW-NM) with software version 1.0P, 1.1.1A, 1.5H, 1.5.1A and 2.0Q -Field Test Period A nuclear medicine image display and processing application suite that provided software applications used to process analyze and display medical images/data.
Code Information Model Number 882488: EBW NM Special Model Number 882489: Extended Brilliance Workspace NM Model number 728260: Extended Brilliance Workspace Serial numbers: 66762, 66790 66146 66001, 66002 66235, 66812, 66820 67160 12344, 66393, 66398, 66418, 66422 12502, 66351 66193, 66223, 66921 66208, 66213, 66217 66952, 66959, 67056 66016 66564 66590, 66591, 66595 66065 66895 66685, 66733, 66735, 66736 66098 66553 66673 66257, 66260 66660, 67126 C66319 67319 66362, 66370 66558 12510 67123 66683 12718 14312 66800 66481 66042, 66194, 66727 66953 66662 12540 66579 66107, 66168 66551 67009, 67014 66077 66641, 66643 66212 C66326 66295 66140, 66379 66088 66097 66367 67274 66674 66723 66778 66599 66196, 66863, 66899 66114 66020, 66021, 66170 C66507 67004 66661 66716 66406 66821 66040 66242, 66244 67065 66687, 66701 67064 66070 66402 67140 66222, 66354 67308 66729, 66741, 66751, 66913 67204, 67208 66104 66782, 66788 66882 67122, 66818A, 66819A 66421 66721 66835 67206 66456 66695, 66699 67285 66209, 66504 66932 66652 67191 66602, 66658 C66331 67217 66901 66468 66697, 66700, 67180 66363, 66369 66382, 66384, 66464, 666112 66717 66575 67280, 67315 66409 66286 67055 66237 66902 66448 66872 12334 66839 66709 66905 67125 66671, 66711, 66726 66621 C66513 67046 66412 66019 66436, 66615, 66710 67057, 67172 66843 67109 66912 66025 66136, 66137, 66252, 66259, 66263, 66306, 66307, 66310, 66311 66400 C66502 66167 66440, 66659 67213, 67214 66452 66636, 66663, 67184, 67187, C66327, C66341 66268, 66555, 67157, 67162, 67167 66761 12624, 12639 66582 66483 67216, 67237 12606 67003, 67059 66004, 66006 67005, 67013, 67170 67255 66649 66570 66844 66926, 66928, 66936 66890 66132, 66728 66494, 66946 66078, 66081 66879 66381 66497 66737 67006 66229 66285 66598, 66600, 66601 67271 66688 66298, 66350, 66360 66038, 66051, 66052 66227 66067 66383 66055, 67212 66186 66753, 66008, 66012 66607 67230, 67234 66180 66568 66813, 66837 66900 66493, 66498 66487, 66489, 67158 66931 66183 66732 67176, 67269 66619 12266, 12269 66686 C66320 C66509, C66510 66754, C66500 66757, 66763, 66764 66552 66707 66438 66884 66950, 66954 66130, 66131, 66133, 66945 66560 66787 66791, 66795, C66342, C66344 66368 67151, 67231 66182 66608, 66609 66634 66109, 66152 67288, 67294 66403, 66405, 66466 66410, 66496 12131 66894, 66935 66429, 66476 66876, 67021, 67022, 67030 66625 66958, 66960 66148, 66154, 67070 C66339 66450, 67233 66829 66749 67264 66846 66877 66783 12355 66197 66583 12334, 12335, 12340, 66393, 66395, 66404, 66414, 66425, 66427, 66435, 66444, 66445, 66449, 66453, 6645566462, 66462 66809 66123, 66127 66224, 66718 13174, 13176, 66144, 66394, 66480 66240, 66613 66887, 66889 66574, 66585 66740, 66744 66893, 66896, 66907,67185, 67198, 66106, 66230 66645 66115 67020, 67023, 67024, 67028 66680 C66349 66747, 66748 66108, 66850 67053 66647, 66691 66376, 66387 12825 67111, 67113, 67134, 67169 66799, C66345, C66346 66245, 66784 66102, 66105 66702 66039 66218 66927, 66933 66916, 66918, 66957 66703, 66705 66071, 66074, 66075 67232 12517, 12519, 66177, 66202 66266, 66282, 66807 66554 66411, 66415, 66469 C66512 66041, 66054 12437, 66014, 66015, 66018, 66022, 66031, 66035, 66420, 66441, 66575, 66593, 66603, 67044 67000, 67017, 67054, 67142 66848, 66851, 67084, 67092 66231, 66233, 66249, 66267, 66271, 66355 66299 66397, 67026, 67040 66808 67007, 67011 66169, 66175, 66767, 66768, 66769, 66770 66565, 66586, 66589 66471, 66477 66875, 66898, 66947, 66948 66801, 66802 66597, 66604, 66606 66232, 66234, 66955, 66962 66189, 66377 67175 66236, 66246, 66269, 66275 66084, 66089, 66092 67268, 67257 66796, C66511 66883 66903, 66914 12516, 66017, 66024, 66592 66592 66437, 66439 66353, 66380 66648, 66656, 66666, 66096 66296, 66357 66143, 66184, 66199, 66283, 66287, 66364 66047, 66053, 66057, 66068, 66069, 66099, 66100, 66118, 66121, 66125, 66126, 66149, 66156 67190, 67192 66103, 66159, 66191, 66192, 66198 66644, 66670, 66672, 66681, 67226 66712, 66713, 66888, 66904, 66956 67200, 67201 67077, 67002 9300 66805, 66823, 66832, 66833, 66840, 66841, 66842 66029, 66033, 66044 66704 66443 66792, 66734, 66906 11728, 11774, 66000 66793 66689, 66690 66794, 66798, 66836 66365 66049, 66190 67183 11875, 11876 66490, 66492 8689 66073 66056, 66059, 66451 66569 66550, 67182, 67292, 67286 67174, 67177 66488 67220 67272, 67276 67293 12635, 12642, 66467 C66314, C66315 66881, 66944 67195 12736, 12737, 12738 C66300 12433, 66220 12368, 12371 12728, 12729 11799, 66200 66797 66584 66007, 66096, 66101, 66484 66618, 66730 66082 66390 66389, 66482 66239 66358, 66485, 66614, 66633 66627, 666113 66214 66622 66961, 67088 12404 66164, 66165 66171, 66204 66682, 66815 66824 13442, 13554, 13555 12715, 67146, 66284 66675 67079 66566 66562, 66572, 66573 66720 67278, 67282 66580 66859 67082 66086, 66909, 66911, 66930 66495 67145, 67165 66826 67062 67043 66715 67090 67263 67001, 67012 66201 66172, 66251 66878 66273, 66290 67211 12357, 66816, 66830, 66834 66392 66979, 66980 66966 66773, 66810 66662 66852, 66855, 67076 67093 67080 66215 67015 66247 67246 66776 66288 66920, 66925 66083 66746 66861 67130 66775 66974, 66975, 66977 66588 66873, 66922, 67283 66581 13193, 66243, 66698 66692, 66719 66766, 66770 66027, 66036, 66043, 66045 67039 66312 12607 66258 66653, 66678, 67018 12613, 12615, 66076 67210 66860 66113 66915 66473 66502 66630 66623 66009, 66011 66058, 66060 66866, 66870 67254 66973 66620 C66323 66640, 66642, 67029, 67221, 67225, 67227 66771 66187, 66248 66868 66090 67085 66428 67238 13040, 66371, 66374 66201, 66228 66085, 66093, 66094 66447, 66454 67036 66155, 66160 67189, 67338 66458 66417, 66419 66651, 66667 66270, 66276 66226, 66274 66862 67164 66122, 66162 13126, 13144 67188 66386, 66388 C66328 66929 67281 66869, 67236, C66324 66777 C66334 C66317 66759, 66867 C66325 66446 66871 66738 66091, 66128, 66129 67194, 67229, 67265, 67277, 67279, 67168F 66655 67025, 67049, 67066 66509 66460 67193 66561 66279, 66472, 66677 66976, 66978 67139 C66342 C66340, C66503 C13070 66173 66206 C66329 C66322 67222 66141, 66145 12975, 12977 67069, 67166, 67173 66768, 66769, 66785, 67179 66938 66724 66157, 66161, 66293 67124 66506 66571 C66348, C66508 67041 66254 66664 66845, 66847, 66849, 66856, 12964, 12978 66116 12644 66124, 66163 67197 66828 66941 C66301 66087, 66111, 66923 66188 66650 66743 66305 66668 66475 12721 66062, 66063 66818, 66819, 67008, 67016 67186 66461 12779, 12785 12375 66706, 66745 66864 66238, 66142 C66313 66361 67108 66147, 66158 66665 66080, 66117 66211 66765 67034, 67118 66563 66166, 66838, 66806A 66611, 66612 66865 66265, 66277 13346, 13347, 13354 66297 C66504 66066, 66151 66178 66289 67052, 67178 66886 66216 66857 67154 66858 66262 67137 12878 66825 66512 66399 13263 66241 66372, 66375 13364 12877, 66510 13264 66939, 66940 13175 66880, 66892 67273 66359 67031, 67050, 67058 12982, 12993 66731 66817, 66822, 66908, 66910, 67027 66626 66594 67270, 66352 66714 12372 66617 66610 12575 12566, 12572, 12576, 12577 67063 66205, 66219, 66416, 66423, 66432, 66654, 66679, 66676 66046 67252 66272, 66278 66030, 66032 66684 66657 67138 66378 67037 66261 67148 66853 66804, 66814, 66827 66153 66972 C66316 12532 12362 66005 C66304, C66309 C66321 66174, 66179 C66333 66023 C66501 13216 67019 66037, 66291, 66292 66739 66253, 66255, 66628, 66629, 66631, 66635, 66638, 67083 66806, 66811, 67087, 67094 66280 66176 66181 66003, 66072, 66366 12387 66391 66491 66119 66470 66185 66772, 66774 C66303 12910 66616 67074 66708 66587 67239 66781 66478, 66576 66250, 66256 66897, 67091 66207, 66373 66578, 66596 11331 C66332, C66335 66624, 66632, 66654 67181 66885 66110, 66112, 66221, 66225, 66457, 66459, 66474 66356, C66505 66750 12508, 66026 66203 66891 67033, 67042, 67117, 67127 66064 66079 C66337 66722 12378, 12384, 12395 66637 66969.
Recalling Firm/
Manufacturer
Philips Medical Systems
3860 N 1st St
San Jose, California 95134-1702
For Additional Information Contact Kumudini J. Carter
440-483-3032
Manufacturer Reason
for Recall
A problem related to a software error has been detected in the Philips Multiple Gated Radionuclide Angiocardiography (MUGA) application. A false negative interpretation due to a falsely elevated ejection fraction or a false positive interpretation due to a false low ejection fraction could occur.
FDA Determined
Cause 2
DESIGN: Software Design
Action Philips sent all affected sites an Urgent Medical Device Correction Letter on September 27, 2011 for the MUGA issue. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review the information contained in the letter with all members of their staff who need to be aware of the contents of the communication. Customers were asked to retain a copy of the communication with the equipment instruction for use. Additionally, a field change order was released on September 26, 2011, customers will be receiving release notes as part of their correction informing them of the changes and corrections to the software. The new software will be installed on affected units by Philips Field Service Engineers. For customers in North America contact Customer Care Solutions Center at 1-800-722-9377. Select option 5. In all other countries contact the local Philips Healthcare office.
Quantity in Commerce 1181 systems
Distribution Worldwide Distribution - USA (nationwide) and Canada.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LLZ and Original Applicant = MARCONI MEDICAL SYSTEMS, INC.
510(K)s with Product Code = LLZ and Original Applicant = PHILIPS NUCLEAR MEDICINE, INC
-
-