Z-0422-2007

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

Name: Z-0422-2007 iE33 Ultrasound System (System, imaging, pulsed doppler, ultrasonic and system, imaging, pulsed echo...
Creator: Philips Ultrasound, Inc.
Published: 2006-11-02
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2006-11-02 / Terminated

FDA source

Philips Ultrasound, Inc. began a recall of iE33 Ultrasound System (System, imaging, pulsed doppler, ultrasonic and system, imaging, pulsed echo, ultrasonic) on 2006-11-02. The reason FDA records is "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)". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0422-2007
Status: Terminated
Initiated: 2006-11-02
Posted: 2007-02-17
Terminated: 2009-07-14
Recalling firm: Philips North America LLC
Product: iE33 Ultrasound System (System, imaging, pulsed doppler, ultrasonic and system, imaging, pulsed echo, ultrasonic)
Product code: IYN System, Imaging, Pulsed Doppler, Ultrasonic
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 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 in commerce: 619 domestic units, 706 international units
Distribution: Worldwide
Product codes and lots: 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, 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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, 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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

Product code IYN

K030455Class IIBoris Platform Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. / cleared 2003-03-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)