—#49224

Product

iE33 Ultrasound System (System, imaging, pulsed doppler, ultrasonic and system, imaging, pulsed echo, ultrasonic)

FDA product code: IYN — System, Imaging, Pulsed Doppler, Ultrasonic
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K030455
Affected lot / code info: 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

Why it was recalled

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)

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Philips Ultrasound, Inc.
Address: 22100 Bothell-Everett Hwy. P.O. Box 3003, Bothell, Washington 98041-3003

Distribution

Distribution pattern: Worldwide

Timeline

Recall initiated: 2006-11-02
Posted by FDA: 2007-02-17
Terminated: 2009-07-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #49224. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.