Events

Recall of Device Recall iE33 Ultrasound System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Philips Ultrasound, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    36722
  • Event Risk Class
    Class 2
  • Event Number
    Z-0422-2007
  • Event Initiated Date
    2006-11-02
  • Event Date Posted
    2007-02-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-07-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49224
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Ultrasound System - Product Code IYN
  • 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).
  • 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.

Device

Device Recall iE33 Ultrasound System
  • Model / Serial
    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
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide
  • Product Description
    iE33 Ultrasound System (System, imaging, pulsed doppler, ultrasonic and system, imaging, pulsed echo, ultrasonic)
  • Manufacturer
    Philips Ultrasound, Inc.

Manufacturer

Philips Ultrasound, Inc.
  • Manufacturer Address
    Philips Ultrasound, Inc., 22100 Bothell-Everett Hwy., P.O. Box 3003, Bothell WA 98041-3003
  • Source
    USFDA