Philips Medical Systems (Cleveland) Inc: Medical Device Recall in 2015 - (Recall #: Z-1598-2015)

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

Class II

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.

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.

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.

Voluntary: Firm initiated