BEUDAMED
    FDA Enforcement Class II Terminated

    Nuclear Gamma Cameras (ADAC Vertex Classic, ADAC VERTEX PLUS/SOLUS/CARDIO, ADAC VERTEX V60) Philips Medical Systems, Cleveland, OH

    Recall: Z-1598-2015 · Reported May 20, 2015

    Enforcement

    Recall Number
    Z-1598-2015
    Event ID
    71190
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips Medical Systems (Cleveland) Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 20, 2015
    Initiation Date
    March 13, 2015
    Classification Date
    May 12, 2015
    Termination Date
    June 26, 2018
    Address
    595 Miner Rd, N/A, Cleveland, OH, 44143-2131, United States

    Description

    Nuclear Gamma Cameras (ADAC Vertex Classic, ADAC VERTEX PLUS/SOLUS/CARDIO, ADAC VERTEX V60) Philips Medical Systems, Cleveland, OH

    Reason

    During clinical use of a Vertex Plus Gamma Camera, as the detector heads were in the relative 180 degree position, Detector #1 drifted down and made contact with the patients chin during a whole body study acquisition.

    Code Info

    Vertex Classic; Model #: 890122; Serial #s: 9404100, 9601238, 9609084, 0407V, 0682V, 0795V, 0822VP2, 103, 20, 500, 5405V, 64, 9308007, 9309020, 9310032, 93-10660-1292, 9401059, 9401061, 9403076, 9403083, 9404106, 9407122, 9409148, 9410002, 9411006, 9411007, 9411016, 9501049, 9501210, 9502067, 9502086, 9503003, 9503079, 9503109, 9504019, 9505021, 9505124, 9506140, 9508169, 9508171, 9508184, 9508193, 9509198, 9509206, 9510222, 9510226, 9601146, 9602249, 9608042, 9901004, B0106154, B02120033, M@10229AMT, M@207JD, M@4404V, M@4431V, M@4432V, M@4480V, M@4623V, M@4630V, M@4639V, M@4686V, M@4692V, M@4858V, M@4893V, M@4959V, M@5032V, M@5033V, M@5038V, M@5105V, M@5145V, M@5158V, M@5189V, M@5280V, M@5289V, M@5338V, M@5360V, M@5373V, M@5398V, M@5407V, M@5412V, M@5431V, M@5439V, M@5467V, M@5476V, M@5497V, M@5498V, M@5515V, M@5526V, M@5590V, M@5617V, M@5627V, M@5661V, M@5662V, M@5663V, M@5665V, M@5681V, M@5688V, M@5689V, M@5751V, M@5752V, M@5782V, M@5811V, M@5835V, M@5869V, M@5900V, M@5913V, M@5915V, M@5960V, M@5970V, M@6004V, M@6007V, M@6010V, M@6056V, M@6900V, M@9304RV, M@9645RV, M@MVS5236V, M@MVS5852V, M@O1325, UNK-AMT1238A. VERTEX PLUS/SOLUS/CARDIO: Model #: 88297; Serial #s: 9603015, 9605036, 9610076, 9610077, 9703171, 9706192, 9710103, 9711277, 9802304, 9803109, 9807121, 9808122, 9809056, 9809124, 9809415, 9809424, 9912461, _0002032, ~9608052, 0007001M, 0008009B, 0011002B, 0102019V, 0103020V, 01069VM, 01070VM, 0111001V, 01295VM, 01296K, 01864VM, 03026VM, 0939VM, 100098-01N, 1006, 1008, 10252, 1027, 1037, 10630, 1092, 1097, 11, 130234-01NVERTEX, 2035, 2038, 2047, 3059, 3060, 3064, 4007, 4078, 5934V, 6052, 6261, 7373VM, 7376VM, 7386VM, 7560VM, 7561VM, 8002, 802080322, 85247, 9054VM/V, 9056VM/V, 9073152, 9130VM, 9205345, 940384, 9408136, 9503084, 9504096, 9506016, 9506145, 9507163-CN, 9511123, 9512008, 9512009, 9512018, 9601015, 9601036, 9601240-CN, 9602161, 9602245, 9602246, 9602254, 9603336, 9604016, 9604021, 9605026, 9605037, 9606211, 9607015, 9607024, 9608046, 9608049, 9608050, 9608052, 9608064, 9609063, 9609081, 9610058, 9611003, 9611077, 9611082, 9612072, 9701127, 9702061-CN, 9702095, 9702150, 9703154, 9704044, 9704178, 9704183, 9705004, 9705186, 9706005, 9706182, 9706189, 9707002, 9707047, 9707050, 9707054, 9708062, 9708065, 9708068-CN, 9708069, 9708076, 9708078, 9708084, 9708227, 9709022, 9710121, 9710127, 9710244, 9711025, 9711034, 9711036, 9711074, 9711078, 9711261, 9711271, 9801047, 9801227, 9801232, 9801297, 9801299-CN, 9802050, 9802255, 9802260, 9802300, 9802306, 9802397, 9803003, 9803014, 9803067, 9803083, 9803269, 9803272, 9803288, 9803290, 9803293, 9803295, 9803312, 9803316, 9803322, 9804069, 9804330, 9804333, 9804342, 9805344, 9805350, 9806006, 9806014, 9806363, 9806377, 9806388, 98066002, 9807002, 9807391, 9807421, 9808036, 9808090, 9808108, 9808451, 9808452, 9808457, 9808480, 9808829, 9809062 (-CN), 9809065-CN, 9809067, 9809113, 9809122, 9809125, 9809498, 9809687, 9810075, 9810136, 9810428ADAC#7973VM, 9810442, 9810551, 9810557, 9811020, 9811093, 9811569, 9811737, 9812582, 9901597, 9901605, 9902150, 9902622, 9902630, 9903632, 9903637, 9903641, 9904089, 9905012, 9905659, 9905667, 9906670, 9907016, 9907017, 9907019, 9907029, 9909161, 9910031, 9911458, 9911698, 9911702, 9912181, 9912463, AD1261, AMT00848VM, B0006129, B0007273, B0008003, B0008012, B0008021, B0008030, B001200212, B0105138, B0106169, B01070191, B01070192, B0107179, B01080204, B01080207, B01090227, B01100231, B01100233, B01100238, B01110251, B02050071, B02050262, B02060167, B02060270, B02060279, B0206027S, B02070290, B02070300, B0207296, B02080318, B0208312, B02090327, B02090333, B02090334, B02100345, B03010355, B03010359, B03020048, B03080380, C0008070, C01080152, C01080154, C03050230, C03060193, M@10458, M@10573, M@10582, M@10589, M@10772, M@10837, M@10850, M@10927, M@10967, M@11020, M@11036, M@11109, M@11140, M@11178, M@11498, M@11525, M@11571, M@11590, M@11881, M@11949, M@11957, M@11972, M@12219, M@12412, M@12591, M@12711, M@12787, M@13010, M@13296, M@13466, M@13498, M@13543, M@13549, M@13665, M@13688, M@13691, M@13748, M@13813, M@22752, M@28051, M@4750019856, M@5828J, M@5906N, M@5919J, M@5936N, M@5956J, M@5961K, M@6002J, M@6012J, M@6075VM, M@6108VA, M@6123VA, M@6160VM, M@6183VA, M@6258J, M@6323VM, M@6324J, M@6330VA, M@6341VA, M@6345VA, M@6346VM, M@6348VM, M@6349VM, M@6365VM, M@6368J, M@6370VA, M@6375J, M@6376J, M@6460VM, M@6464VM, M@6470VA, M@6481VA, M@6496VM, M@6528VA, M@6541VA, M@6542VM, M@6566VM, M@6573VM, M@6596VM, M@6600VA, M@6638VM, M@6639J, M@6675VA, M@6716VM, M@6717VM, M@6762VM, M@6773VM, M@6776VM, M@6797K, M@6805VM, M@6823VM, M@6840K, M@6841VM, M@6867VM, M@6877VM, M@6886VM, M@6891VA, M@6924VM, M@6931VM, M@6932VM, M@6943VM, M@6946VM, M@6947J, M@6985J, M@7003VA, M@7004VA, M@7005VA, M@7017VM, M@7024VM, M@7034K, M@7042VM, M@7053VM, M@7073VM, M@7085K, M@7086J, M@7095VM, M@7100VM, M@7101VM, M@7102VM, M@7151VM, M@7153VM, M@7159VM, M@7166K, M@7171VM, M@7172K, M@7181J, M@7190VM, M@7198VA, M@7215K, M@7216VM, M@7217VM, M@7221VA, M@7222VA, M@7229VM, M@7233VM, M@7237VM, M@7245J, M@7246VM, M@7247VM, M@7250VM, M@7300J, M@7308VM, M@7376VM, M@7380VM, M@7384VM, M@7390VM, M@7393VM, M@7394VM, M@7410VM, M@7420VM, M@7464VA, M@7470VM, M@7490VM, M@7494K, M@7501VM, M@7504VM, M@7505VM1, M@7514VM, M@7515VM, M@7536VM, M@7537VM, M@7538VM, M@7556VM, M@7557VM, M@7569VM, M@7572VM, M@7591VM, M@7592VM, M@7603K, M@7605VM, M@7606VM, M@7623K, M@7626K, M@7627K, M@7628VA, M@7638VM, M@7643VM, M@7654VM, M@7664VM, M@7665K, M@7673VM, M@7674K, M@7679VM, M@7682K, M@7685VM, M@7691VM, M@7695VM, M@7697VM, M@7723VM, M@7729VM, M@7733VM, M@7739K, M@7760VM, M@7761VM, M@7770VM, M@7776VM, M@7789K, M@7801VM, M@7810VM, M@7811VM, M@7812VM, M@7819VA, M@7823K, M@7824VM, M@7830K, M@7855J, M@7857VM, M@7860VM, M@7861VM, M@7874VM, M@7877VM, M@7918K, M@7924K, M@7925K, M@7929VM, M@7930VM, M@7932VM, M@7946J, M@7957VM, M@7961VM, M@7962VM, M@7965VM, M@7968VM, M@7975K, M@7987VM, M@7995VM, M@7997VM, M@8004VM, M@8013VM, M@8018J, M@8021VM, M@8044VM, M@8060VM, M@8064VM, M@8076K, M@8089VM, M@8096VM, M@8105VM, M@8124VA, M@8124VA, M@8146VM, M@8155VM, M@8178VM, M@8203VM, M@8219VA, M@8220K, M@8240K, M@8241VM, M@8248VM, M@8252VM, M@8284K, M@8301K, M@8302VM, M@8306K, M@8337VM, M@8356K, M@8380VM, M@8399VM, M@8484VM, M@8528VM, M@8537VM, M@8551VM, M@8561K, M@8606K, M@8609VM, M@8651VM, M@8683VM, M@8686K, M@8693VM, M@8726VM, M@8738K, M@8759K, M@8771VM, M@8781VM, M@8797K, M@8799RV, M@8800VM, M@8803K, M@8812VM, M@8814VM, M@8882K, M@8888K, M@8897K, M@8903K, M@8906RK, M@8920VM, M@8922VM, M@8935K, M@8948RV, M@8955K, M@8990K, M@8996VM, M@9032K, M@9046K, M@9049VM, M@9081K, M@9091VM, M@9107RV, M@9166VM, M@9185K, M@9194VM, M@9221VM, M@9222VM, M@9247RV, M@9252VM, M@9267VM, M@9309RV, M@9316VM, M@9327K, M@9338VM, M@9340VM, M@9360VM, M@9369VM, M@9418VM, M@9426K, M@9438K, M@9471RV, M@9515VM, M@9532VM, M@9542VM, M@9543K, M@9583VM, M@9607VM, M@9653VM, M@9672VM, M@9724VM, M@9730K, M@9816K, M@9831VM, M@AMT1258, M@MCD6416VM, M@MCD7036VM, M@R372820, M@S5195VA, M@S5365-V, M@S5820VM, M@S5907V11, M@S6155VA, M@S7156VM, M@S7223K, M@S7559VA, M@S7571VM, M@S7856K, M@S7864K, M@S7904VM, M@S7941VA, M@S8687K, M0101023, R03010363, S0011003, S6235VM, STOR_QUO_47521360, UNK-6597VM, UNK-7590VM, UNK-8533VM1, UNK-8860VM, UNK-9868K, V0007070, V0010090, V0012099, V0104109, V0104110, V0105112, V0106121, V0106123, V0106124, V01070133, V01090146, V01100149, V01100151, V01100156, V02050166, V02070174, V02070179, V02080190, V02080194, V02080199, V02080200, V02090206, V03060224, V03070229, V03091241. VERTEX V60 Model #: 882030; Serial #s: 9601243, 9602253, 9603008, 9603013, 9604028, 9604041, 9605033, 9606038, 9610256, 9704175, 9704177, 9801284, 9803324, 9807089, 9810434, 9904005, 970001-9610187, M0007018, V0009076, V0011096, V0106122, V0106125, V02050163, V02050165, V02070181, 9705007, 9711262, 00559VM, 00634V, 00657VA, 00970VA, 01190VM, 01697VM, 01894VM, 0371V, 10588, 1189-17, 12001, 1273-06, 1274-06, 9601004, 9607063, 9707206, 9710247, 9712001, 9712008, 9712009, 9803003, 9806019, 9808021, 9902027, 9909039, M0007001-CN, V0005062, V01090141, V01090142, V03080235, V03080236, V2070177, VETEJ, X0005002, X0010004, X0101006, X0101007, X03030012, Z00657VA, Z01798VM.

    Distribution

    Worldwide Distribution - US (nationwide) including Puerto Rico and to the states of : AL, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI and WV., and to the countries of : Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Costa Rica, Denmark, Egypt, France, Germany, Ireland, Italy, Japan, Lebanon, Malaysia, Netherlands, Norway, Pakistan, Portugal, Republic of Korea, Russia, South Korea, Spain, Sweden, Syrian Arab Republic, Thailand and United Kingdom.

    Quantity

    918 units