Events

Rappel de Device Recall VERTEX EPIC MCD, GENESYS II

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Philips Medical Systems (Cleveland) Inc.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    71190
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1598-2015
  • Date de mise en oeuvre de l'événement
    2015-03-13
  • Date de publication de l'événement
    2015-05-12
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2018-06-26
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=136423
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    System, tomography, computed, emission - Product Code KPS
  • Cause
    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.
  • Action
    Philips sent an Customer Information letter dated March 16, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to : 1. Do not lubricate the clutch(es) with oil, grease or any other type of lubricant.. 2. Follow product Instructions For Use (IFU), CARDIO. SOLUS, ADAC VERTEX, AND ADAC VERTEX PLUS WITH ATLAS USERS MANUAL, 9201-0227E-ENG, REV A- General Precautions that instructs user to monitor the patient during scanning. 3. Follow product Instructions For Use (IFU), CARDIC, SOLUS, ADAC VERTEX, AND ADAC VERTEX PLUS WITH ATLAS USER'SMANUAL, 9201-0227E-ENG, REV A- Emergency Patient Removal, Section Safety and Regulatory Agency Compliance, page 2-11, instruction(s) on emergency patient removal. 4. Ensure completion of product Preventive Maintenance (PM) procedure requiring inspection of the radius drive clutches every 3 months for contamination and replacement if contaminated and, testing of the gantry system. If you need any further information or support concerning this issue, please contact your local Philips representative: Technical Support Line: 1-800-722-9377.

Device

Device Recall VERTEX EPIC MCD, GENESYS II
  • Modèle / numéro de série
    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.
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • 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.
  • Description du dispositif
    Nuclear Gamma Cameras (ADAC Vertex Classic, ADAC VERTEX PLUS/SOLUS/CARDIO, ADAC VERTEX V60) Philips Medical Systems, Cleveland, OH
  • Manufacturer
    Philips Medical Systems (Cleveland) Inc

Manufacturer

Philips Medical Systems (Cleveland) Inc
  • Adresse du fabricant
    Philips Medical Systems (Cleveland) Inc, 595 Miner Rd, Cleveland OH 44143-2131
  • Société-mère du fabricant (2017)
    Philips
  • Source
    USFDA