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Recall Observatory FDA recall evidence

Device product

Nuclear gamma cameras (ADAC Vertex Plus, ADAC Solus, ADAC Vertex V60 & ADAC Vertex Classic) Philips Medical System, Cleveland, OH 44143. Used to produce images depicting the anatomical distribution of single photon and positron emitting radioisotopes with the human body for interpretation by medical personnel.

Z-1510-2014

March 10, 2014

Class II

Product summary

Firm
Philips Medical Systems (Cleveland) Inc
Event
Event 67901
Status
Terminated
Classification
Class II
Quantity
1,043 cameras
Official record key
device-enforcement:Z-1510-2014

Official wording

Reason: Slippage of the radius drive belt in the relative 180 degree orientation of the superior positioned detector head will allow the detector head to drift down and potentially come in direct contact with the patient.

Code information: ADAC Vertex Plus & ADAC Solus System Code: 88297, Serial #'s: 11, 1006, 1008, 1027, 1092, 1097, 2035, 2038, 2047, 3059, 3060, 3064, 4007, 4078, 6052, 6261, 8002, 10252, 10630, 11090, 85247, 513519, 513520, 940384, 9205345, 9408136, 9503084, 9506016, 9511123, 9512009, 9512018, 9601012, 9601015, 9601016, 9601024, 9601036, 9602161, 9602254, 9603336, 9604016, 9604021, 9605024, 9605026, 9605037, 9606211, 9607015, 9607024, 9608031, 9608046, 9608049, 9608052, 9609063, 9609081, 9610058, 9611035, 9611077, 9611082, 9612072, 9702095, 9702150, 9703154, 9703165, 9704044, 9704178, 9704183, 9705004, 9705186, 9706005, 9706182, 9706189, 9707002, 9707047, 9707050, 9707054, 9708062, 9708065, 9708076, 9708078, 9708084, 9708088, 9708227, 9709022, 9709061, 9710121, 9710127, 9710244, 9711025, 9711034, 9711036, 9711074, 9711271, 9711291, 9801047, 9801227, 9801232, 9801297, 9802050, 9802255, 9802260, 9802300, 9802306, 9802397, 9803003, 9803014, 9803067, 9803083, 9803269, 9803272, 9803288, 9803290, 9803293, 9803295, 9803303, 9803312, 9803316, 9804069, 9804330, 9804333, 9804342, 9805344, 9805350, 9805376, 9806014, 9806363, 9806377, 9806388, 9807391, 9807421, 9808036, 9808090, 9808108, 9808451, 9808452, 9808457, 9808480, 9808829, 9809067, 9809113, 9809122, 9809125, 9809498, 9809687, 9810075, 9810136, 9810551, 9810557, 9811020, 9811093, 9811569, 9811737, 9812582, 9901162, 9901597, 9901605, 9902150, 9902622, 9902630, 9903632, 9903637, 9903641, 9904089, 9905003, 9905012, 9905659, 9905667, 9906670, 9907016, 9907019, 9909011, 9909161, 9910015, 9910017, 9910031, 9911458, 9911698, 9911702, 9911711, 9912181, 9912463, 98066002, 802080322, 0002032, 0007001M, 0008009B, 0011002B, 0101002C, 0102019V, 0103020V, 01069VM, 01070VM, 0111001V, 01295VM, 01296K, 01864VM, 03026VM, 0939VM, 100098-01N, 130234-01NVERTEX, 5934V, 6090VM, 7373VM, 7376VM, 7386VM, 7560VM, 7561VM, 9054VM/V, 9056VM/V, 9130VM, 9806373A, 9810428ADAC#7973VM, 9894K, AD1261, AMT00848VM, B0006129, B0007273, B0008001, B0008003, B0008012, B0008021, B0008030, B001200212, B0102114, B0104125, B0104128, B0105138, B0106169, B01070191, B01070192, B0107179, B01080199, B01080204, B01080207, B01090227, B01090228, B01100231, B01100232, B01100233, B01100236, B01100237, B01100238, B01100241, B01100242, B01110251, B01110252, B02050071, B02050262, B02050263, B02050265, B02060167, B02060270, B02060279, B0206027S, B02070289, B02070290, B02070291, B02070297, B02070300, B0207296, B02080318, B0208312, B02090327, B02090334, B02100345, B02110348, B02120352, B03010355, B03010359, B03020048, B03080380, C0006050, C0006051, C0007060, C0008070, C0009075, C0101099, C0102103, C0102108, C0104118, C0107145, C01080152, C01080153, C01080154, C02100218, C02110220, C02120223, C03010227, C03050230, C03060193, CNF, M@10458, M@10482, M@10547, M@105561, M@10573, M@10582, M@10589, M@10591, M@10676, M@10772, M@10837, M@10839, M@10848, M@10850, M@10871, M@10878, M@10882, M@10927, M@10937, M@10967, M@10979, M@11015, M@11020, M@11036, M@11103, M@11109, M@11140, M@11178, M@11184, M@11381, M@11398, M@11423, M@11498, M@11525, M@11571, M@11590, M@11609, M@11644, M@11881, M@11939, M@11949, M@11957, M@11972, M@12060, M@12219, M@12412, M@12591, M@12711, M@12787, M@13010, M@13296, M@13466, M@13498, M@13543, M@13549, M@13663, M@13665, M@13688, M@13691, M@13748, M@13813, M@14062, M@22752, M@28051, M@4750019856, M@5828J, M@5906N, M@5919J, M@5936N, M@5956J, M@6002J, M@6012J, M@6075VM, M@6076K, M@6077K, M@6108VA, M@6123VA, M@6143VA, M@6160VM, M@6183VA, M@6244VA, M@6258J, M@6323VM, M@6324J, M@6330VA, M@6341VA, M@6344VM, M@6345VA, M@6346VM, M@6348VM, M@6349VM, M@6365VM, M@6366K, M@6368J, M@6370VA, M@6371VM, M@6375J, M@6376J, M@6460VM, 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@6769K, M@6771VM, M@6773VM, M@6776VM, M@6797K, M@6805VM, M@6823VM, M@6840K, M@6841VM, M@6867VM, M@6877VM, M@6886VM, M@6891VA, M@6912K, 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@7070VM, M@7073VM, M@7085K, M@7086J, M@7095VM, M@7096VM, M@7099K, M@7100VM, M@7101VM, M@7102VM, M@7108VM, M@7109VM, M@7151VM, M@7166K, M@7171VM, M@7172K, M@7181J, M@7190VM, M@7198VA, M@7205K, 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@7253K, M@7300J, M@7308VM, M@7358VA, M@7376VM, M@7380VM, M@7384VM, M@7390VM, M@7393VM, M@7394VM, M@7410VM, M@7420VM, M@7463VM, M@7464VA, M@7470VM, M@7490VM, M@7494K, M@7501VM, M@7503VM-FU1, 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@7624K, 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@7740VM, M@7760VM, M@7761VM, M@7770VM, M@7776VM, M@7789K, M@7801VM, 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@7963K, M@7965VM, M@7968VM, M@7975K, M@7987VM, M@7995VM, M@7997VM, M@8004VM, M@8018J, M@8021VM, M@8044VM, M@8064VM, M@8076K, M@8089VM, M@8096VM, M@8105VM, M@8124VA, M@8146VM, M@8155VM, M@8178VM, M@8203VM, M@8219VA, M@8240K, M@8241VM, M@8247K, M@8248VM, M@8252VM, M@8284K, M@8301K, M@8302VM, M@8306K, M@8337VM, M@8356K, M@8380VM, M@8394K, M@8399VM, M@8436K, M@8462VM, M@8484VM, M@8491K, M@8510VM, M@8528VM, M@8537VM, M@8540K, M@8544K, M@8551VM, M@8561K, M@8606K, M@8609VM, M@8651VM, M@8683VM, M@8686K, M@8692VM, 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@8817RK, M@8876K, M@8882K, M@8884K, M@8888K, M@8897K, M@8903K, M@8906RK, M@8920VM, M@8922VM, M@8935K, M@8936K, M@8942K, M@8943K, M@8948RV, M@8955K, M@8966K, M@8967K, M@8990K, M@8996VM, M@900K, M@9032K, M@9041K, M@9046K, M@9049VM, M@9063K, M@9080K, M@9081K, M@9085K, M@9091VM, M@9107RV, M@9118K, M@9129K, M@9131K, M@9140K, M@9166VM, M@9185K, M@9186K, M@9191K, M@9194VM, M@9221VM, M@9222VM, M@9231K, M@9247RV, M@9252VM, M@9267VM, M@9283K, M@9293VM, M@9308K, M@9309RV, M@9316VM, M@9327K, M@9337K, M@9338VM, M@9340VM, M@9344K, M@9349K, M@9360VM, M@9418VM, M@9426K, M@9434K, M@9442K, M@9452K, M@9471RV, M@9476K, M@9479K, M@9479K, M@9480K, M@9502K, M@9515VM, M@9522K, M@9525K, M@9532VM, M@9542VM, M@9543K, M@9562K, M@9563K, M@9566K, M@9583VM, M@9590K, M@9594K, M@9598K, M@9607VM, M@9609K, M@9622K, M@9639K, M@9646K, M@9653VM, M@9672VM, M@9712K, M@9724VM, M@9730K, M@9765K, M@9769K, M@9799K, M@9816K, M@9831VM, M@9834K, M@9837K, M@AMT1258, M@MCD6416VM, M@MCD7036VM, M@O1317, M@R372820, M@S5195VA, M@S5365-V, M@S5820VM, M@S5907V11, M@S6155VA, M@S7115VM, M@S7156VM, M@S7223K, M@S7559VA, M@S7571VM, M@S7817K, M@S7856K, M@S7864K, M@S7904VM, M@S7941VA, M@S8687K, N@9369VM, R03010363, S0011003, S6235VM, UNK-6597VM, UNK-7590VM, UNK-8097J1, UNK-8533VM1, UNK-8860VM, UNK-9868K, V0007070, V0012099, V0104109, V0104110, V0105112, V0106121, V0106123, V0106124, V01070133, V01090146, V01100151, V01100156, V02050166, V02070174, V02070179, V02080190, V02080194, V02080196, V02080200, V03060224, & V03070229. ADAC Vertex V60 System Code: 882030; Serial #'s: 10588, 9601004, V0005062, V03080235, V03080236, & V2070177. ADAC Vertex Classic System Code: 890122; Serial #'s: 64, 103, 500, 3334, 5005, 9308007, 9309020, 9310032, 9401059, 9401061, 9403076, 9404106, 9407122, 9410002, 9411006, 9411016, 9501210, 9502067, 9502070, 9503003, 9503079, 9503109, 9504019, 9504099, 9505021, 9505124, 9506140, 9506178, 9508171, 9508184, 9508193, 9509206, 9510222, 9510226, 9601146, 9602249, 9608042, 9609084, 9901004, 9901135, 0407V, 0682V, 0795V, 0822VP2, 20, 5405V, 93-10660-1292, 9408128, 9411007, 9502086, 9508169, 9509198, 9509199, B0106154, B02120033, M@10229AMT, M@207JD, M@4324V, M@4404V, M@4431V, M@4432V, M@4480V, M@4623V, M@4630V, M@4639V, M@4686V, M@4692V, M@4835V, 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@5398V, M@5407V, M@5412V, M@5431V, M@5439V, M@5467V, M@5474V, M@5476V, M@5497V, M@5498V, M@5515V, M@5526V, M@5590V, M@5617V, M@5627V, M@5661V, M@5662V, M@5663V, M@5664V, 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@9374RV, M@9645RV, M@MVS5236V, M@MVS5852V, M@O1325 & UNK-AMT1238A.

Distribution pattern: Worldwide Distribution -- USA, and the countries of Australia, Austria, Belgium, Brazil, Canada, China, Denmark, Egypt, France, Germany, Hong Kong, Ireland, Italy, Korea, Lebanon, Malaysia, Netherlands, Norway, Pakistan, Portugal, Russia, Singapore, Spain, Sweden, Thailand, & United Kingdom.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Slippage of the radius drive belt in the relative 180 degree orientation of the superior positioned detector head will allow the detector head to drift down and potentially come in direct contact with the patient.