Philips Ultrasound, Inc.: iE33 Ultrasound System (System, imaging, pulsed doppler, ultrasonic and system, imaging, pulsed echo, ultrasonic)

Recall number

Z-0422-2007

Recalling firm

Philips Ultrasound, Inc.

Product

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

Status

Terminated

Initiated

2006-11-02

Posted

2007-02-17

Terminated

2009-07-14

Reason

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

Other

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

619 domestic units, 706 international units

Distribution

Worldwide

Lot, serial or model codes

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

510(k) numbers

["K030455"]

PMA numbers

not on file

Product code

IYN

Firm FEI

3019216

Firm city

Bothell

Firm state

WA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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