Events

Retiro De Equipo (Recall) de Transesophegeal Ultrasound Transducer

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Sonosite, Inc..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    49374
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2191-2010
  • Fecha de inicio del evento
    2008-08-08
  • Fecha de publicación del evento
    2010-08-09
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-08-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73226
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    System, imaging, pulsed echo, ultrasonic - Product Code IYO
  • Causa
    The tee transesophageal transducer, when connected to a sonosite m-turbo ultrasound system, may exhibit erratic operation of the scanplane orientation indicator on the system display. the indicator may move erratically and not accurately represent the orientation of the tee transducer array.
  • Acción
    On August 21, 2008, SonoSite began calling 15 consignees who have purchased the TEE/8-3 MHz Transducer and an M-Turbo 1.1 system. The firm provided instruction to discontinue use the system to 11 consignees and left voice messages to the remaining four consignees. On August 21, 2008, SonoSite sent out the URGENT-MEDICAL DEVICE CORRECTION letter and the Urgent Field Safety Notice to all affected consignees in the US and in foreign countries. The URGENT-MEDICAL DEVICE CORRECTION letter describes the recall product as TEE/8-5 MHz Transducer, SonoSite Part Numbers P05183 and P06841. The letter informed the consignees that the TEE transesophageal transducers may exhibit erratic operation of the Scanplane Orientation Indicator on the system display when it connected to the SonoSite M-Turbo Ultrasound System. The letter instructs consignees to discontinue use of the TEE/8-3MHz Transducer with the M-Turbo (or Micromaxx system) immediately, while the firm is working to create a software solution to resolve the issue and offers customers a software upgrade within 6-8 weeks. The consignees are also advised to forward the recall notice to others who need to be aware of the issue or where the potentially affected devices have been distributed. Customers should call the Technical Support at 1-1-425-951-1330 or 1-877-657-8118 from Monday to Friday, 6 am-5 pm PST or e-mail to service@sonosite.com for any questions regarding the recall.

Device

Transesophegeal Ultrasound Transducer
  • Modelo / Serial
    Part number P05813 and P06841  Serial numbers: DOMESTIC: 03B3G4, 03B7BJ, 03BKK9, 03CWKJ, 037XL6, 034J4X, 034T2R, 038fdn, 03BKJH, 03B3FT, 039F3H, 03BC26, 03CJTD, 03CHVH, 039F3L, 034Z4M, 03CWKD, 0354HB, 039F3J, 039F3Q, 03B3G3, 0354HC, 03B7B3, 0354HD, 03BKJ0, 03BKJK, 0356LC, 0360X5, 03BC2B, 03CVVH, 03CCBT, 0377LT, 038WXY, 03BC25, 037MR9, 037XPX, 03B3FY, 037XQ1, 03B3FX, 0392RC, 03B3G0, 0356FB, 035G72, 035NT0, 038WTJ, 03BKJF, 038WY1, 038WY3, 038WY5, 03CHVG, 03B3FW, 03CJ7D, 0392R8, 03CHVM, 03B3FV, 03936X, 0361FF, 0354J0, 0377LQ, 03CWCX, 0379T3, 037F5D, 03BC2G, 037X7R, 035NT3, 0384GM, 0392LP, 0360X7, 0376PB, 03936W, and 03BKKC.    INTERNATIONAL: 035G71, 038FDP, 039V7L, 0356C3, 037XQ5, 0384K6, 0392RH, 03CJ83, 0377LN, 0392RG, 039KD3, 039V7P, 039V7T, 03BC24, 03BC2D, 03BKJJ, 03BKKY, 038WRH, 03CCBQ, 0384FH, 039KD4, 03BC20, 034PGZ, 034PH0, 03CCBR, 03BC23, 03CWKL, 034T2T , 03B7B2, 0384FL, 0384GN, 0384K4, 0384K5, 038WRD, 0390MH, 039190, 03918Z, 03BKKW, 03CJ82, 03CJ7B, 03CJ81, 03CJ86, 03CJ87, 03CJ88, 037XL7, 0384BX, 038WY7, 034PGQ, 0392RL, 034PGV, 03BC2C, 0392R9 , 039196 ,03CHVF, 03CJTB, 03CJTC, 034T30, 03570P, 0354HF, 0377LP, 038FL4 , 03CCBP, 03CWKF, 037MR7, 037XPW, 037MR6, 0384FJ, 034TN9, 0356HM, 038WTM, 0356GL, 034T32 , 039198, 0360YT , 0384CZ, 0384D1, 0361G5, 03B7B2, 03BKJG, 03CHVD, 03CJ7C, 03CJ84, 03CJ8B, 03CVVJ, 034T2W , 0356BV , 0377LV, 037MRC, 038WRJ, 039F3R, 0361DN, 036GYG, 037LTV, 037MR8, 037XQ3, 034PGX 035TZK, 034P7Y, 034PGM, 034PGP, 0356BW, 035G9X, 035NT2, 0361G6, 036GYD, 037F1Y, 037LTQ, 037LTT, 037LTY, 037M8T, 037XPY, 038WY2, 039V7M, 03CWD1, 03CWKM, 038XKX, 034NMJ, 0356C2, 034T2V, 034T2X, 034TNW, 034TNZ, 0354H9, 0356LD, 0360YV, 037XL8, and 0390MC.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA and countries including Argentina, Austria, Belgium, Brazil, Canada, Chile, Croatia, Czech Republic, Denmark, Finland, France, Germany, India, Iran, Ireland, Israel, Italy, Korea, Netherlands, New Zealand, Poland, Slovenia, South Africa, Spain, Switzerland, and Thailand.
  • Descripción del producto
    SonoSite TEE, 8-3 MHz Transducer labeled: "Tee Transducer... SonoSite, Inc. 21919 30th Drive SE Bothell, WA 98021". || The TEE/8-3 MHz Transducer is designed for 2D, M Mode, color Doppler, pulse wave (PW) Doppler and continuous wave (CW) Doppler by applying ultrasound energy through the esophagus or stomach of the patient into the heart. The TEE transducer is intended to be used on adults only. Backscattered ultrasound energy from the patient's heart is used to form images of the heart to detect abnormalities in structure or motion, to evaluate the velocity of blood flowing within the heart, and to obtain a color depiction of the velocities of blood flowing in the heart.
  • Manufacturer
    Sonosite, Inc.

Manufacturer

Sonosite, Inc.
  • Dirección del fabricante
    Sonosite, Inc., 21919 30th Dr Se, Bothell WA 98021-3904
  • Source
    USFDA