—#96561

Product

PCR Eleva. The marketing brochure is labeled in parts: "Philips Medical Systems is part of Royal Philips Electronics... www.medical.philips.com... Philips Medical Systems Nederland B.V". Provides one or more capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images.

FDA product code: LLZ — System, Image Processing, Radiological
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K964124
Affected lot / code info: Site Numbers: 540174, 540902, 543457, 544694, 547848, 547849, 549554, 559966, 42047944, 42047945, 42047946, 42636410, 42636411, 42636457, 42785029, 44620447, 44620448, 44621161, 44892290, 45168464, 45311836, 506103, 44621154, 44621155, 541714, 538773, 539440, 541324, 541389, 541390, 541391, 541392, 541393, 544526, 545356, 42132637, 42132835, 42132836, 42132837, 42132841, 42799764, 42799768, 42799772, 42799784, 42799787, 42799822, 44038390, 44038393, 532267, 532268, 532269, 537619, 537627, 537633, 537650, 538445, 538505, 538506, 538507, 538508, 538701, 538702, 538979, 538980, 539061, 539430, 539431, 539432, 539433, 539434, 539436, 539437, 539438, 539439, 539441, 539442, 539443, 539449, 539450, 539451, 539452, 539453, 539619, 539664, 539740, 539741, 540294, 540352, 540357, 540358, 540359, 540360, 540369, 540428, 540429, 540430, 540489, 540496, 540637, 540966, 540997, 540998, 541035, 541066, 541240, 541252, 541254, 541255, 541307, 541326, 541346, 541349, 541398, 541399, 541400, 541437, 541616, 541618, 541713, 541826, 541828, 541829, 541889, 541893, 541901, 541902, 541904, 541909, 541915, 542108, 542164, 542165, 542166, 542167, 542168, 542169, 542170, 542188, 542189, 542190, 542246, 542247, 542249, 542254, 542377, 542383, 542410, 542600, 542639, 542640, 542641, 542642, 542665, 543413, 543414, 543416, 543417, 543418, 543419, 543421, 543424, 543603, 543604, 543605, 543606, 543612, 543613, 543614, 543615, 543631, 543632, 543693, 543719, 543758, 543825, 543830, 543831, 543927, 543940, 544089, 544115, 544194, 544281, 544381, 544588, 544592, 544595, 544685, 544686, 544688, 544689, 544690, 544691, 544875, 544940, 545015, 545016, 545054, 545055, 545263, 545287, 545352, 545353, 545354, 545361, 545362, 545363, 545364, 545379, 545380, 545381, 545430, 545431, 545566, 545567, 545825, 545845, 545886, 545887, 545892, 545893, 545908, 546003, 546167, 546168, 546169, 546170, 546171, 546172, 546173, 546174, 546175, 546483, 546484, 546485, 546486, 546487, 546488, 546489, 546619, 546678, 546690, 547179, 547412, 547670, 547672, 547702, 547829, 547830, 547831, 547847, 547863, 547868, 547869, 547883, 547964, 548106, 548109, 548256, 548257, 548259, 548325, 548327, 548328, 548578, 548623, 548748, 548750, 548774, 548856, 548857, 548858, 548987, 549111, 549256, 549266, 549267, 549268, 549324, 549351, 549377, 549388, 549529, 549530, 549647, 549710, 549821, 549870, 549898, 550042, 550043, 550090, 550114, 550115, 550134, 550135, 550266, 550267, 550268, 550269, 550270, 550272, 550273, 550274, 550275, 550295, 550296, 550305, 550320, 550335, 550341, 550342, 550386, 550816, 550817, 550929, 550938, 550939, 550958, 551002, 551003, 551018, 551276, 551343, 551354, 551356, 551411, 551419, 551430, 551432, 551438, 551439, 551440, 551442, 551509, 551520, 551521, 551542, 551672, 551839, 552076, 552083, 552119, 552120, 552144, 552145, 552174, 552212, 552213, 552253, 552254, 552400, 552415, 552443, 552521, 552522, 552654, 552655, 553053, 553120, 553209, 553210, 553291, 553331, 553332, 553333, 553334, 553335, 553338, 553339, 553386, 553388, 553444, 553641, 553643, 553721, 553901, 553927, 554091, 554095, 554325, 554404, 554405, 554406, 554445, 554446, 554530, 554531, 554532, 554533, 554534, 554535, 554536, 554537, 554538, 554558, 554582, 554595, 554613, 554616, 554617, 554618, 554623, 554624, 554625, 554626, 554627, 554632, 554657, 554718, 554795, 554796, 554800, 554801, 554857, 554876, 555017, 555121, 555270, 555385, 555386, 555388, 555389, 555390, 555408, 555476, 555522, 555665, 555666, 555697, 555709, 555745, 555782, 556018, 556090, 556091, 556133, 556163, 556164, 556175, 556176, 556178, 556179, 556233, 556519, 556551, 556665, 556793, 556837, 556843, 556860, 556864, 556869, 556957, 557023, 557162, 557164, 557285, 557286, 557287, 557288, 557350, 557571, 558415, 558421, 558516, 558517, 558518, 558519, 558520, 559769, 559941, 559942, 41443580, 41443588, 41443651, 41443724, 41443730, 41443733, 41443734, 41443736, 41443740, 41443780, 41443903, 41444566, 41444659, 41444757, 41445116, 41445143, 41445155, 41445331, 41445391, 41445406, 41445485, 41445586, 41445722, 41445738, 41445813, 41445824, 41445825, 41445831, 41445847, 41445858, 41445859, 41445861, 41445862, 41445867, 41445868, 41445869, 41445920, 41445926, 41445930, 41445932, 41446133, 41446318, 41541166, 41622509, 41704403, 41711727, 41747703, 41780360, 41781481, 41782214, 41782216, 41795153, 41796624, 41896219, 41938045, 42057214, 42057216, 42057217, 42066438, 42066439, 42066440, 42066441, 42122306, 42123337, 42248659, 42326712, 42373510, 42373516, 42392282, 42572848, 42573637, 42575723, 42608440, 42616791, 42681385, 42733785, 42824083, 42861599, 42865625, 42865626, 42865627, 42865628, 42866042, 42868067, 42868068, 42868069, 42869023, 42869024, 42869040, 42869090, 42869099, 42877564, 42892349, 42892350, 42892351, 42892352, 42975073, 42976502, 43016231, 43084789, 43191088, 43191785, 43209144, 43209145, 43209146, 43209147, 43209148, 43209149, 43209150, 43209151, 43209152, 43209153, 43209154, 43209155, 43273958, 43304526, 43394975, 43453755, 43453756, 43495013, 43504224, 43557517, 43645552, 43670905, 43691426, 43691427, 43691428, 43693170, 43693190, 43717665, 43718623, 43848154, 43860972, 43902585, 43902654, 43927326, 43959688, 43959689, 43959690, 44064829, 44216825, 44281797, 44328596, 44337100, 44469259, 44469264, 44488265, 44488344, 44500965, 44561177, 44561178, 44604134, 44615336, 44623917, 44642293, 44654099, 44706046, 44743559, 44781013, 44869929, 44869930, 44869931, 45074597, 45140095, 10386, 85175, 86027, 86028, 86029, 86030, 86239, 86240, 101892, 102832, 102935, 103769, 105172, 105354, 105400, 105401, 105701, 105709, 505051, 505716, 519108, 519109, 519110, 519111, 519112, 520407, 520408, 520528, 520672, 520673, 520704, 520931, 521891, 536615, 544490, 544491, 545888, 551834, 555510, 50159257, 50159268, 50159342, 551966, 539444, 505128, 544282, 553208, 43637238, and 43794689.

Why it was recalled

There is a risk of selecting the wrong patient, when patient is selected in the patient list and the examination tab pressed with background query are running at the same time.

Root cause (FDA determination)

Software design

Action the firm took

On 1/30/2009, Philips began sending out URGENT-Device Correction PCR Eleva notifications to their consignees. The consignees were informed of the hazards as when a patient is selected in patient list and examination tab pressed with background query running at the same time, there would be a risk that the wrong patient is selected. The firm issued the Field Corrective Order (FCO) 73200029 to their representative to correct the problem. The corrective action would be a software upgrade that resolve the issue. All consignees can contact Philips Call Center at 800-722-9377, #5, #2 and reference "FCO 73200029" with any questions.

Recalling firm

Firm: Philips Medical Systems North America Co. Phillips
Address: 22100 Bothell Everett Hwy, Bothell, Washington 98021-8431

Distribution

Distribution pattern: Nationwide Distribution -- USA, including states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WI, WV, and WY and to LANDSTUHL ARMY BASE, APO in United Arab Emirates.

Timeline

Recall initiated: 2008-12-23
Posted by FDA: 2011-02-04
Terminated: 2011-08-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #96561. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.