CLASS II Device recall · Reported 20 May 2015 · FDA Enforcement Report
Nuclear Gamma Cameras (Adac Vertex Classic recalled
Philips Medical Systems (Cleveland) is recalling Nuclear Gamma Cameras (Adac Vertex Classic, Adac Vertex Plus/Solus/Cardio, Adac Vertex, distributed nationwide in the US. The recall was initiated on 13 Mar 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1598-2015
- FDA event ID
- 71190
- Recalling firm
- Philips Medical Systems (Cleveland), Cleveland, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 Mar 2015
- FDA classified
- 12 May 2015
- Reported
- 20 May 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 13 Mar 2015 | Recall initiated by company | |
| 12 May 2015 | Classified by FDA | +60 days |
| 20 May 2015 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Product as listed by the FDA
Nuclear Gamma Cameras (ADAC Vertex Classic, ADAC VERTEX PLUS/SOLUS/CARDIO, ADAC VERTEX V60) Philips Medical Systems, Cleveland, OH
Where it was distributed
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.
Nationwide AlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaDelawareFloridaGeorgiaIowaIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMaineMichigan
Questions about this recall
Why was it 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.
Which lots are affected?
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.
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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