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U.S. Department of Health and Human Services

Class 2 Device Recall iE33 Ultrasound System

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 Class 2 Recall
iE33 Ultrasound System
see related information
Date Posted February 17, 2007
Recall Status1 Terminated on July 14, 2009
Recall Number Z-0422-2007
Recall Event ID 36722
Premarket Notification
510(K) Number
K030455 
Product Classification System, Imaging, Pulsed Doppler, Ultrasonic - Product Code IYN
Product iE33 Ultrasound System (System, imaging, pulsed doppler, ultrasonic and system, imaging, pulsed echo, ultrasonic)
Code Information Base id numbers: 02RCZW, 02KHVQ, 02L57V, 02L5HV, 02KG8D, 02LJ5B, 02LJBB, 02RC00, 02HWQJ, 02BV73, 02LFMR, 02HXCQ, 02KHQ7, 02HWRH, 02HWT2, 02LJ1R, 02RC92, 02KHWF, 02LHZT, 02L6Y3, 02L6Z7, 02RC8Y, 02KHMD, 02LJ85, 02KHXP, 02KHWK, 02KHZH, 02HXP2, 02HXPN, 02D391, 02KJ47, 02L54X, 02RC0Y, 02RC11, 02L598, 02KHQQ, 02RC7B, 02LJBC, 02KHLC, 02KHJ1, 02KHMX, 02LFKV, 02LFKW, 02LFMB, 02LFML, 02LFMP, 02LJP0, 02RCFT, 02RCY3, 02RCXZ, 02RCQL, 02RCXC, 02D38B, 02BV74, 02DPCL, 02LJ56, 02LJ47, 02LJL3, 02RD0X, 02HWQ5, 02D3VM, 02RCXG, 02L4TW, 02RCHN, 02L5KG, 02RC0Q, 02LJ5L, 02L6B4, 02L6F6, 02L5RZ, 02LJPL, 02KH91, 02KH87, 02KHG5, 02HXKQ, 02HXL5, 02HWV9, 02RCXX, 02HXBW, 02HXN6, 02KJ3L, 02L6W7, 02L552, 02HXFX, 02RCV6, 02KHPD, 02KHNW, 02KHPT, 02KHNQ, 02L6YX, 02L5NP, 02DPL9, 02DPK5, 02KJ5Y, 02DPMN, 02KHMY, 02L51R, 02L57W, 02KHHH, 02KHHW, 02LJJH, 02LJK8, 02L6CD, 02L559, 02KHKM, 02RCX6, 02RCWB, 02RCX7, 02RCPJ, 02LJ0M, 02L50F, 02KHVH, 02BVM0, 02L5XW, 02RCHP, 02RCW8, 02RCW5, 02RCW6, 02RCJN, 02RCY1, 02LJ0J, 02RCV8, 02KHG1, 02L5L9, 02KH9J, 02L52X, 02LJ8K, 02LJ91, 02BV6Z, 02LJ0V, 02LJ0P, 02LJ08, 02L4XN, 02RC10, 02RC1W, 02RC27, 02RC28, 02KH8C, 02LJ09, 02D28Y, 02HXJR, 02KHVK, 02KHQX, 02KHX4, 02LJ4D, 02LJC1, 02LJB6, 02LJ96, 02LJBD, 02LJBG, 02L6CC, 02HWRJ, 02L5X0, 02L6QV, 02L5MF, 02HXL7, 02L66Y, 02L66Z, 02L6M9, 02L4Z8, 02RCTK, 02DQBF, 02HWRK, 02LJC5, 02LJG1, 02LJDD, 02LJKC, 02LJKZ, 02LFJB, 02BVJ6, 02LJ3F, 02LJ1N, 02L603, 02L5WJ, 02L6FL, 02L6F5, 02LJKT, 02RCZX, 02D4BK, 02DPFV, 02L6NP, 02D4C2, 02DQ10, 02RD05, 02RCHQ, 02HX8L, 02LJM6, 02L6H9, 02RD01, 02RCZY, 02RCZR, 02LJ0K, 02LJ0Z, 02LJ1G, 02LJ1K, 02LK02, 02LK09, 02RCWC, 02RCW9, 02KHB1, 02LHYK, 02LHYG, 02DPXK, 02BV72, 02HWQ0, 02RCCF, 02RCMW, 02RCM8, 02RCZZ, 02RCBC, 02RCM5, 02L56K, 02L6NQ, 02RCZP, 02L4XH, 02L51Q, 02HXTK, 02HXTN, 02HWW9, 02DR1W, 02KHVX, 02LJ1Y, 02LJ2R, 02HWPT, 02RCTG, 02KHBL, 02KHBM, 02KHC3, 02DPMV, 02DQNF, 02DPMR, 02RCPL, 02LJ1C, 02L70Z, 02DQP4, 02DQNX, 02HXR3, 02HXQK, 02HXR4, 02HXTG, 02HXTV, 02DPDT, 02KH5M, 02L6R5, 02L6RR, 02DPPW, 02KHY8, 02L51K, 02L70R, 02KHDT, 02KHPW, 02RCX8, 02RCX9, 02L57J, 02L4Z1, 02DPPT, 02DR25, 02HWTF, 02LHZV, 02DP8Q, 02L6N8, 02DP9T, 02DPB7, 02DPB9, 02DPPD, 02DPP8, 02DP8P, 02DP86, 02RCRR, 02HXD9, 02HXDD, 02HXDH, 02HXF0, 02LFNR, 02RC16, 02RCW3, 02KHT4, 02RCB3, 02RC88, 02KJ6F, 02KG8F, 02KHJL, 02HX54, 02HX55, 02HX5B, 02HX7H, 02HX7V, 02HXHQ, 02LJCR, 02LJDR, 02L5G5, 02L5CK, 02RCF4, 02RCMX, 02RCMY, 02RCM2, 02L4YM, 02L57X, 02L591, 02L6LX, 02L50Y, 02KHXB, 02KH71, 02L4YG, 02BVLZ, 02DQNJ, 02HX7X, 02HXJH, 02RCZN, 02RCWY, 02RCVB, 02D413, 02RD06, 02HXBY, 02RCXB, 02RCY2, 02DQJH, 02L6N0, 02L6MD, 02DR27, 02HXC0, 02L6MZ, 02L6BP, 02HXBG, 02HX7Y, 02L5QK, 02LJ1J, 02LJC0, 02LJ1H, 02LHZ2, 02L5RY, 02LJ2Q, 02LJ38, 02L6QT, 02HXPL, 02L6YM, 02LHYH, 02KHVW, 02RCG8, 02LFMX, 02L706, 02KJ1V, 02RD00, 02HXN0, 02HWT3, 02KHTM, 02HXKL, 02L5Z8, 02L6R3, 02KHT8, 02LFMW, 02RC0P, 02KHQZ, 02RCN0, 02RCXD, 02DPDP, 02L6J9, 02LFH9, 02LK0Y, 02LK10, 02RCRQ, 02HWZV, 02HX8B, 02L50K, 02KJ0H, 02KJ0N, 02LJNM, 02LJM4, 02LJK9, 02LJKX, 02HXMG, 02HXMB, 02HXKK, 02HXKN, 02LHYD, 02KG8C, 02HXHW, 02L4XG, 02KHRN, 02HXP5, 02KHRH, 02DPWZ, 02RCLF, 02BTMJ, 02HWPZ, 02RCX3, 02KHJH, 02HXFP, 02KHMF, 02KH9H, 02KHM5, 02KHM7, 02HXD5, 02LJH4, 02LJKJ, 02LJKH, 02LJM5, 02L6GX, 02RD10, 02HXR2, 02LJF8, 02L6TB, 02LJH3, 02LJG7, 02D3VK, 02HXHN, 02HWXL, 02RCXH, 02LFHB, 02L67L, 02L61D, 02HWV8, 02HXBV, 02LJDN, 02LJH2, 02LJ1Z, 02LJ9R, 02LK0X, 02LJ8Q, 02RCRP, 02RCV9, 02L6G9, 02L6Y6, 02L6QW, 02LJ88, 02RCQJ, 02KHM2, 02RCJB, 02L4XJ, 02L56N, 02L55C, 02HXBH, 02L6GY, 02KH5L, 02RC01, 02DPP9, 02L6KX, 02HXK9, 02RCZT, 02L4Y7, 02L6C4, 02KHXL, 02L4YH, 02L6V2, 02L6V3, 02L6MY, 02RC7Q, 02RC7P, 02RC5N, 02RC7Y, 02LFMD, 02LFMM, 02LFNL, 02RC08, 02RC0V, 02RC14, 02KHHR, 02L699, 02L68J, 02L68F, 02L6B2, 02L70N, 02LJ1V, 02LJCY, 02LJ5N, 02L5G6, 02D4C3, 02DP9Q, 02DPQP, 02KHW0, 02KHQ3, 02HWTX, 02KHNR, 02RCJJ, 02RC29, 02RCTD, 02HXHP, 02LJJG, 02LJ5M, 02KHQ9, 02LJP1, 02L6BG, 02L5FY, 02KG8H, 02KHVL, 02RCC1, 02RCFW, 02L5P8, 02LFMK, 02L5VC, 02L5PP, 02RCZQ, 02RCTC, 02L605, 02L60X, 02RD0Z, 02DPRK, 02DPTZ, 02RD04, 02RD12, 02RD13, 02L6ZN, 02LJC9, 02RCM4, 02DPQR, 02HWRG, 02KHPZ, 02DPVB, 02KHXN, 02KHWJ, 02RC5J, 02KJ42, 02RCT7, 02LK0B, 02L5FH, 02RCX4, 02L71D, 02L70T, 02LHZ4, 02L5TC, 02L6V6, 02HXF5, 02HXPT, 02L602, 02RCPP, 02LFMC, 02KHP9, 02KHRM, 02RCY4, 02RCY5, 02RCXY, 02RD0Y, 02RCHM, 02RCTN, 02RCW7, 02RCVC, 02RD03, 02L6Q6, 02L681, 02LFMZ, 02LFMG, 02LFMJ, 02LFM9, 02LFMV, 02LFN2, 02HXBM, 02HWZF, 02L6K9, 02L6KW, 02L6Y9, 02LJ4B, 02L6NX, 02L6LV, 02KJ5X, 02RCZV, 02RCPR, 02L6NB, 02HX53, 02HXNL, 02D4BG, 02HWT0, 02L6GB, 02L6FT, 02L5MP, 02L69C, 02L6B0, 02L6GD, 02L6MB, 02L6LY, 02L6KC, 02RCRV, 02RCRT, 02KHD5, 02HXL2, 02RC7T, 02DPQ6, 02L4WW, 02DPZV, 02L6BF, 02L6BC, 02L69B, 02L68N, 02L68G, 02L662, 02L64N, 02L64Z, 02L64P, 02HWQ6, 02LJKK, 02LJ2N, 02KJ0G, 02RCB1, 02RCXF, 02RCTP, 02KJ5P, 02L4VC, 02L4VH, 02L667, 02L663, 02L64Y, 02L64Q, 02L682, 02L683, 02L67X, 02L67N, 02L63T, 02L61F, 02DQ3N, 02KH89, 02LFMT, 02HXNK, 02RCY0, 02HXJG, 02LFMN, 02RC17, 02RC2B, 02RC2Q, 02L6XC, 02L6NC, ** added international base numbers 02/14/2007** 02D450, 02DPRG, 02HWWQ, 02HX5R, 02HXFZ, 02HXH6, 02HXK6, 02KH41, 02KHRR, 02KHVF, 02KHVM, 02KJ5N, 02L4W0, 02L66H, 02L6N9, 02L6RT, 02LJ19, 02LJP8, 02LK05, 02RCW2, 02RCX0, 02HWZH, 02L6DB, 02L6RV, 02D4C0, 02DPLF, 02KHML, 02KHKH, 02KHNZ, 02D415, 02D44P, 02D4C1, 02DPCG, 02DPLB, 02DPMT, 02DPPB, 02DPPR, 02DPQ4, 02DPQ5, 02DPQN, 02DPR4, 02HWTW, 02HWXJ, 02HWZG, 02HX01, 02HX8H, 02HXB3, 02HXBX, 02HXFN, 02HXGF, 02HXGR, 02HXGV, 02HXH5, 02HXQ8, 02HXRL, 02HXTT, 02KHDW, 02KHM9, 02KHN1, 02KHNY, 02KHWG, 02KHXQ, 02KHXR, 02KHYC, 02KHZV, 02KJ1Q, 02KJ27, 02KJ4C, 02L4XF, 02L4YN, 02L50Z, 02L52C, 02L5G7, 02L5HR, 02L5N7, 02L5PC, 02L60R, 02L62T, 02L671, 02L69F, 02L6B1, 02L6LF, 02L6LZ, 02L6MC, 02L6MX, 02L6Q5, 02L6W5, 02L6WZ, 02L6XM, 02L70P, 02L70Q, 02L710, 02LFMQ, 02LJ2V, 02LJJ0, 02LJJ1, 02LJL1, 02RC5M, 02RC8Z, 02RC91, 02RCBF, 02RCGC, 02RCHK, 02RCT9, 02RCV7, 02RCX1, 02HXG8, 02KHZW, 02DPML, 02DPMQ, 02HWQG, 02HWY7, 02HX56, 02HX68, 02HXG9, 02HXHX, 02HXK7, 02HXKB, 02HXN7, 02KH43, 02KH4F, 02KHCH, 02KHCP, 02KHCT, 02KHD7, 02KHMW, 02KHPC, 02KHQ8, 02KHQY, 02KHTP, 02KJ2D, 02L4VN, 02L4X0, 02L4X2, 02L4Z6, 02L5FP, 02L5YB, 02L68K, 02LJ0F, 02LJ4F, 02RC6X, 02RCBK, 02HXQQ, 02RCF3, 02KJ61, 02L4W5, 02RCC2, 02DR0C, 02DR0F, 02DR0X, 02KHBJ, 02KHVC, 02L5J2, 02L5NB, 02L5VH, 02L5WL, 02L6H8, 02L6KT, 02L6NY, 02DPJM, 02DPMP, 02HXM3, 02L4XM, 02L5Q6, 02L6K4, 02LJ36, 02D416, 02D44R, 02DPQ3, 02DQ2W, 02HWZW, 02HXJZ, 02HXKZ, 02KH9K, 02KHFJ, 02KHVR, 02KHX9, 02L5CJ, 02L6LD, 02L6LG, 02L6Y4, 02L6ZR, 02LFH5, 02RC43, 02RCRW, 02RCW4, 02D3DQ, 02D3LX, 02D44Z, 02D4BX, 02DP8K, 02DPJ5, 02DPJK, 02DPJL, 02DQ2X, 02DR0G, 02DR0Q, 02DR1Z, 02HWYQ, 02HWZ9, 02HX8K, 02HX8R, 02HX9T, 02HXLP, 02HXLR, 02KH4D, 02KHKV, 02KHMJ, 02KHQR, 02KJ00, 02KJ17, 02KJ3N, 02L4VG, 02L4WK, 02L4YR, 02L50G, 02L51J, 02L550, 02L5FK, 02L5FQ, 02L5G1, 02L5L4, 02L5NN, 02L5PT, 02L5XH, 02L5XY, 02L5YP, 02L5ZQ, 02L629, 02L62H, 02L63K, 02L63Q, 02L64T, 02L65M, 02L66N, 02L670, 02L6PW, 02L709, 02LHZX, 02LJ0G, 02LJ32, 02LJ3D, 02LJ3H, 02LJ43, 02LJ6K, 02LJ6M, 02LJ6N, 02LJGY, 02LJKV, 02LJKW, 02LJMF, 02LJND, 02RC94, 02RCBG, 02RCJC, 02RCMZ, 02RCPN, 02RCPV, 02DPQQ, 02DQJD, 02HXKC, 02HXKY, 02HXMF, 02KHFK, 02KJ3Q, 02L61C, 02L63M, 02L65N, 02L6NW, 02L6WC, 02L6ZM, 02L718, 02L71C, 02LFK9, 02LJJ5, 02LK16, 02RC42, 02RC6T, 02RC8D, 02RCJD, 02DQNV, 02KHWD, 02L5G3, 02L5K6, 02L5LD, 02L5RL, 02L65R, 02L6GW, 02L6YP, 02LJ0T, 02LJ69, 02LJ7N, 02LJKG, 02LJMB, 02RCCM, 02RCWZ, 02DPDR, 02DR12, 02HXPV, 02HXRP, 02KJ4V, 02KJ6H, 02L4TZ, 02L5XZ, 02LJM9, 02D44L, 02D44T, 02DPJ4, 02DQNG, 02HXHR, 02KHCK, 02KHD6, 02KJ0K, 02KJ0Q, 02L4VT, 02L5LF, 02L6D2, 02L6Q4, 02LFKR, 02DPZT, 02HWR5, 02HWR6, 02HWR7, 02HWR8, 02HWR9, 02HWZB, 02HX64, 02HX65, 02HX8M, 02HXJK, 02HXL8, 02HXL9, 02HXLW, 02HXM2, 02HXM9, 02HXMJ, 02HXMK, 02HXR0, 02HXR6, 02HXRK, 02HXRM, 02HXTF, 02KH64, 02KHBN, 02KHDR, 02KHFF, 02KHFG, 02KHFZ, 02KHJ2, 02KHKT, 02KHLY, 02KHMG, 02KHMH, 02KHMK, 02KHPV, 02KHQP, 02KHTK, 02KHVT, 02KHX5, 02KJ16, 02KJ2F, 02KJ4Z, 02KJ5R, 02L4TY, 02L4VZ, 02L4W3, 02L4WL, 02L50Q, 02L510, 02L526, 02L52B, 02L596, 02L5B6, 02L5CN, 02L5F9, 02L5FC, 02L5FG, 02L5FN, 02L5FW, 02L5FX, 02L5GP, 02L5H4, 02L5HB, 02L5HQ, 02L5J4, 02L5J6, 02L5JG, 02L5JJ, 02L5JL, 02L5K3, 02L5LB, 02L5MD, 02L5N6, 02L5PM, 02L5PN, 02L5TQ, 02L5YF, 02L5YN, 02L60V, 02L60W, 02L61B, 02L62F, 02L63P, 02L63V, 02L6BD, 02L6FW, 02L6FY, 02L6HB, 02L6HW, 02L6RY, 02L6V4, 02L6V7, 02L6VL, 02L6W3, 02L6WH, 02L6XP, 02L6YQ, 02L70J, 02LFHC, 02LFJ1, 02LHYL, 02LHZW, 02LJ26, 02LJ2P, 02LJ4C, 02LJ6Q, 02LJ7H, 02LJ8M, 02LJCX, 02LJDF, 02LJKB, 02LJP3, 02RC4T, 02RC4X, 02RC58, 02RC7X, 02RCB0, 02RCB9, 02RCBD, 02RCCD, 02RCCJ, 02RCF1, 02RCF5, 02RCFY, 02RCG7, 02RCGH, 02RCHT, 02RCJ6, 02RCJL, 02RCLL, 02RCPX, 02RCPZ, 02RCQ3, 02RCQK, 02RCQP, 02RCQR, 02RCTQ, 02RCTB, 2E+299, 02D3VC, 02DP85, 02HWXT, 02HXK4, 02KHLD, 02KHYD, 02L5J9, 02L63H, 02L64W, 02L66M, 02LFJV, 02LJ0C, 02LJGC, 02LJM0, 02RC07, 02RC6W, 02RCTL, 02KJ15, 02LFMY, 02L5HD, 02LJNH, 02D44M, 02D44N, 02D4BB, 02D4BR, 02D4BV, 02DPK3, 02DR08, 02DR09, 02DR0L, 02DR1Y, 02DR26, 02HXCN, 02HXJB, 02HXKJ, 02HXLM, 02KG8G, 02KH3Z, 02KH4K, 02KH56, 02KH57, 02KH5Z, 02KH61, 02KH70, 02KH7G, 02KH7K, 02KH7L, 02KH86, 02KH88, 02KHCR, 02KHDM, 02KHFL, 02KHG6, 02KHG7, 02KHGN, 02KHGR, 02KHH7, 02KHHK, 02KHHQ, 02KHHY, 02KHJG, 02KHJX, 02KHKD, 02KHLB, 02KHM0, 02KHM4, 02KHT5, 02KHWB, 02KHWH, 02KHX6, 02KHZ1, 02KHZF, 02KJ04, 02KJ12, 02KJ13, 02KJ18, 02L4W1, 02L4XX, 02L555, 02L55D, 02L5FV, 02L5HF, 02L5K5, 02L5QM, 02L5Y7, 02L62Z, 02L6DC, 02L6KV, 02L6RB, 02L6W2, 02L6XJ, 02L6Z6, 02L6ZT, 02L707, 02LHZC, 02LHZF, 02LHZZ, 02LJ02, 02LJ03, 02LJ0H, 02LJ3G, 02LJ46, 02LJ67, 02LJ6R, 02LJ7M, 02LJ9Q, 02LJB3, 02LJB4, 02LJBH, 02LJBJ, 02LJDL, 02LJF2, 02LJGD, 02RC7L, 02RC95, 02RCB4, 02RCBH, 02LK17, 02RCJF, 02DP9R, 02DQP5, 02HXM5, 02L5TF, 02L66P, 02LK06, 02L6KZ, 02KHQC, 02L6HZ, 02L6HZ, 02LJJC, 02BVJ7, 02D40N, 02DQP8, 02DR0N, 02HWTJ, 02L68D, 02LFL9, 02RC02, 02RC2V, 02RCB6, 02DPDF, 02DPK4, 02HWZX, 02HX5P, 02KH8Z, 02KH90, 02KHTR, 02L4XW, 02L69H, 02L6K2, 02L6T2, 02LFLG, 02D44V, 02DQ3Q, 02HX5T, 02L5JB, 02L5Z4, 02L63G, 02L64J, 02L6TX, 02L6Z4, 02LJ0B, 02LJ6B, 02LJ7K, 02D4BM, 02HXL4, 02KHHJ, 02KHHM, 02L5FJ, 2E+294, 02DPJ6, 02DR0J, 02KH9G, 02KHK8, 02L6DG, 02L6DJ, 02LFJ7, 02LFKD, 02RC5G, 02RCCL, 02D44Y, 02DPK2, 02DPV0, 02HXJ9, 02L5MH, 02LFLM, 02LFJX, 02LFKT, 2E+290, 02D4BY, 02DQNY, 02DQP0, 02DQPB, 02DR10, 02DR23, 02HWQH, 02HWZY, 02HWZZ, 02HX69, 02HX6T, 02HX93, 02HX94, 02HXB4, 02HXL1, 02HXTR, 02KHC0, 02KHCJ, 02KHCQ, 02KHD2, 02KHKF, 02KHRT, 02KHT9, 02L572, 02L5F3, 02L5L5, 02L5LP, 02L5LV, 02L5M2, 02L5NC, 02L5TG, 02L64X, 02L65L, 02L66J, 02L66K, 02L66Q, 02L6LB, 02L6PV, 02L6RK, 02L6RW, 02L6TC, 02L6TY, 02L6X0, 02L6Z5, 02L712, 02L713, 02L716, 02L71B, 02LFJQ, 02LFKL, 02LFLH, 02LHZB, 02LJF5, 02LJFZ, 02LJGB, 02RC32, 02RC8G, 02RCX2
Recalling Firm/
Manufacturer
Philips Ultrasound, Inc.
22100 Bothell-Everett Hwy.
P.O. Box 3003
Bothell, Washington 98041-3003
For Additional Information Contact Sarah Baxter
425-487-7665
Manufacturer Reason
for Recall
Acoustic output intensity may exceed maximum specified limits and the patient contact temperature may exceed 43 degree C (when the system is used with the S12-4 transducer in CW-mode)
FDA Determined
Cause 2
DESIGN: Software Design
Action On 11/2/06 the firm sent a letter dated October 31, 2006 to their customers. The letter explains the problem and states that new software is being released and will be available sometime in November. Customer service representatives will visit consignees to upgrade their units. The firm later determined they sent letters out to consignees that did not have affected units. Those consignees will be notified the week of 11/20/06 to disregard the previous letter.
Quantity in Commerce 619 domestic units, 706 international units
Distribution Worldwide
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = IYN and Original Applicant = PHILIPS ULTRASOUND, INC.
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