FDAFDA · Food and drugs·Recall number Z-1607-2015
Nuclear gamma cameras (ADAC VERTEX PLUS/SOLUS/CARDIO, ADAC VERTEX V60 & ADAC CARDIO C60) Nuclear gamma cameras intended to produce images depicting the anatomical distribution of single photon and positron emitting radioisotopes with the human body for interpretation by medical personnel.
Published May 20, 2015 · Recall initiated: March 11, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The firm was notified by a customer that the collimator exchange carriage and the collimator storage cabinet were misaligned.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Philips Medical Systems (Cleveland) Inc
- Distributor
- Worldwide Distribution - US (nationwide) to the states of: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and WY., and to the countries of : Australia, Austria, Belgium, Brazil, Canada, China, Costa Rica, Egypt, France, Germany, Hong Kong, Ireland, Italy, Japan, Korea, Lebanon, Netherlands, Norway, Pakistan, Portugal, Russia, Singapore, South Korea, Spain,Thailand and United Kingdom.
- Lot
- VERTEX PLUS/SOLUS/CARDIO Model #88297; Serial #s: 9504103, 9703171, 9802304, 9809124, 9809415, 9810438, 9910015, 9911711, _0002032, 0007001M, 0008009B, 0011002B, 0101002C, 0102019V, 0103020V, 01069VM, 01070VM, 0111001V, 01295VM, 01296K, 01864VM, 03026VM, 0939VM, 100098-01N, 1006, 1008, 10252, 1027, 1062701, 1062701, 10630, 1092, 1097, 11, 11090, 130234-01NVERTEX, 2035, 2038, 2047, 3059, 3060, 3064, 4007, 4078, 5934V, 6052, 6090VM, 6261, 7373VM, 7376VM, 7386VM, 7560VM, 7561VM, 8002, 802080322, 85247, 9054VM/V, 9056VM/V, 9073152, 9130VM, 9205345, 940384, 9408127, 9408136, 9503084, 9504096, 9506016, 9506145, 9511123, 9512008, 9512009, 9512018, 9601012, 9601015, 9601016, 9601024, 9601036, 9602161, 9602245, 9602246, 9602254, 9603336, 9604016, 9604021, 9605024, 9605026, 9605037, 9606211, 9607015, 9607024, 9608031, 9608046, 9608049, 9608050, 9608052, 9608052, 9608064, 9609063, 9609081, 9610058, 9611003, 9611035, 9611077, 9611082, 9612072, 9701127, 9702095, 9702150, 9703154, 9703165, 9704044, 9704178, 9704183, 9705004, 9705186, 9706005, 9706182, 9706189, 9707002, 9707047, 9707050, 9707054, 9708062, 9708065, 9708069, 9708076, 9708078, 9708084, 9708088, 9708227, 9709022, 9709061, 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, 9803303, 9803312, 9803316, 9803322, 9804069, 9804330, 9804333, 9804342, 9805344, 9805350, 9805376, 9806006, 9806014, 9806363, 9806373A, 9806377, 9806388, 98066002, 9807002, 9807391, 9807421, 9808036, 9808090, 9808108, 9808451, 9808452, 9808457, 9808480, 9808829, 9809065-CN, 9809067, 9809113, 9809122, 9809125, 9809498, 9809687, 9810075, 9810136, 9810428ADAC#7973VM, 9810442, 9810551, 9810557, 9811020, 9811093, 9811569, 9811737, 9812582, 9901162, 9901597, 9901605, 9902150, 9902622, 9902630, 9903632, 9903637, 9903641, 9904089, 9905003, 9905012, 9905659, 9905667, 9906670, 9907016, 9907017, 9907019, 9907029, 9909011, 9909161, 9910017, 9910031, 9911458, 9911698, 9911702, 9911711, 9912181, 9912463, 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, B02090333, 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, CANCEL_9809065, 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@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@6345, 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@
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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