Recalls / —

—#136423

Product

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

FDA product code

KPS — System, Tomography, Computed, Emission

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K922080, K952684

Affected lot / 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.

Why it was recalled

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.

Root cause (FDA determination)

Employee error

Action the firm took

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.

Recalling firm

Firm

Philips Medical Systems (Cleveland) Inc

Address

595 Miner Rd, Cleveland, Ohio 44143-2131

Distribution

Distribution pattern

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.

Timeline

Recall initiated

2015-03-13

Posted by FDA

2015-05-12

Terminated

2018-06-26

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #136423. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.