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.
Enforcement
- Recall Number
- Z-1510-2014
- Event ID
- 67901
- 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 7, 2014
- Initiation Date
- March 10, 2014
- Classification Date
- April 25, 2014
- Termination Date
- August 4, 2015
- Address
- 595 Miner Rd, Cleveland, OH, 44143-2131, United States
Description
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.
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.
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.
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.
1,043 cameras