Events

Recall of Device Recall PCR Eleva

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Philips Medical Systems North America Co. Phillips.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    57558
  • Event Risk Class
    Class 2
  • Event Number
    Z-1019-2011
  • Event Initiated Date
    2008-12-23
  • Event Date Posted
    2011-02-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-08-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96561
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Radiological Image Processing System - Product Code LLZ
  • Reason
    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.
  • Action
    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.

Device

Device Recall PCR Eleva
  • Model / Serial
    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.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    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.
  • Manufacturer
    Philips Medical Systems North America Co. Phillips

Manufacturer

Philips Medical Systems North America Co. Phillips
  • Manufacturer Address
    Philips Medical Systems North America Co. Phillips, 22100 Bothell Everett Hwy, Bothell WA 98021-8431
  • Source
    USFDA