Events

Retiro De Equipo (Recall) de Device Recall S83t Micro TEE 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 Philips Medical Systems Nederlands.

¿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
    58320
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2062-2011
  • Fecha de inicio del evento
    2011-03-27
  • Fecha de publicación del evento
    2011-04-25
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-02-14
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98980
  • 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
    Transducer, ultrasonic, diagnostic - Product Code IYN
  • Causa
    Users of the philips model s8-3t micro tee transducer have reported that significant image quality degradation may occur after a number of use/cleaning cycles. if users do not inspect the transducer for such damage prior to each use, imaging may not always be available, which could pose a risk for patients.
  • Acción
    Philips Healthcare began mailing Urgent Medical Device Correction letter on March 28, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers are being instructed on how to inspect the distal tip for defects that cause image quality degradation, and to plan for epicardial / transthoracic ultrasound imaging as an adjunct to the S8-3t. Customers are also reminded to carefully follow cleaning described under Handling the S8-3t Transducer, of Philips' iE33 System User Information. Customers can call Philips Customer Service at 800-722-9377 and reference to FCO 79500198 for any questions about this recall.

Device

Device Recall S83t Micro TEE Transducer
  • Modelo / Serial
    System Code Serial Numbers:  02KHRT, 02L66Z, 02LJ0G, 02LJKW, 02R6K9, 02R8HK, 02R8JJ, 02RB69, 02RBRM, 02RBVK, 02RDQJ, 02RDTX, 02RPDG, 02RPT9, 02X3KY, 02X3RG, 02X3WD, 02X3WD, 02X434, 02X43J, 02X43Y, 02X4JH, 02XDNH, 02XF24, 02XF6J, 02XJXG, 02XK9H, 02XKBF, 02XKCH, 02XKCQ, 02XKCQ, 02XKCY, 02XL54, 02XRN8, 02XT0Z, 02XTHZ, 034JBN, 034K6R, 034KC0, 034L0J, 034L34, 034L4W, 034L5X, 034LDN, 034V9K, 034VL2, 034VMJ, 034VP2, 034VTC, 034VZ0, 034W05, 034W20, 0353HK, 039VGF, 039VPZ, 039VWY, 039VZL, 039W1G, 039W66, 039W86, 039W9X, 039WB4, 039WB8, 039WBY, 039WX8, 039WY1, 039WY2, 039X41, 039X49, 039X99, 039XC1, 039XHG, 039XHG, 03B48J, 03B49T, 03B4GG, 03B4H4, 03B4HC, 03B4JQ, 03B4QR, 03B4V6, 03B4ZX, 03B51R, 03B521, 03B524, 03B566, 03B57R, 03B597, 03B8QB, 03B8RR, 03B8TX, 03B8TZ, 03B8V3, 03B8X1, 03B8X6, 03B8ZY, 03B905, 03B906, 03B90L, 03B912, 03B92H, 03B92H, B008YN, B008YY, B00905, B00919, B009BW, B009FG, B009FY, B009JX, B009MY, B009VM, B009ZW, B009ZW, B00D88, B00DBN, B00DF1, B00DL4, B00DLC, B00DQG, B00DR7, B00DXP, B00DZX, B00F05, B00F11, B00F14, B00F20, B00F3C, B00F5M, B00F5V, B00F61, B00F7J, B00F89, B00HRV, B00J3X, B00J73, B00JCD, B00JG5, B00JK0, B00JKG, B00JMC, B00P7K, B00P7R, B00P9C, B00PB0, B00PDV, B00PFB, B00PGV, B00PKG, B00PM0, B00PMP, B00PPW, B00PQ5, B00PT5, and B00PW4.
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA AL, AR, AZ, CA, CO, DC, DE, FL, GA, IA, IL, KY, LA, MA, MD, MI, MN, MS, NC, ND, NH, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, and WI, and the countries of Australia, Austria, Belgium, Chile, Denmark, Finland, France, Germany, India, Israel, Italy, Japan, Korea Rep, Netherlands, Singapore, South Africa, Spain, Switzerland, Taiwan, Thailand, Ukraine, and United Kingdom.
  • Descripción del producto
    S8-3t Micro TEE Transducer is an Ultrasonic Diagnostic. The Part # is 989605379471. || The User information is labeled in part: "***iE33 Ultrasound System ***User Information Update***4535 614 04811 Rev A***New S8-3t TEE Transducer*** || This release of the iE33 Ultrasound System supports the S8-3t transesophageal echocardiographic (TEE) transducer***Manufactured by Philips Ultrasound***22100 Bothell-Everett Highway***Bothell, WA 98021-8431***USA***Telephone: +1 425-487-7000 or 800-426-2670***Fax: +1 425-485-6080***www.philips.com/ultrasound***". || The S8-3t transducer is indicated for adult cardiac, pediatric cardiac and transesophageal uses, and operates in the following modes: B, M, Color M, CWD, PWD, high PRF, color Doppler, harmonic, XRES. The S8-3t Micro TEE is indicated for use on patients weighing at least 2.5 kg undergoing echocardiography exams in the ICU, echocardiography lab, interventional suite, or in the operating room during cardiac surgery. The S8-3t Micro TEE transducer can be identified by the designation "S8-3t" printed on the connector housing of the transducer.
  • Manufacturer
    Philips Medical Systems Nederlands

Manufacturer

Philips Medical Systems Nederlands
  • Dirección del fabricante
    Philips Medical Systems Nederlands, Veenpluis 4-6, Best Netherlands
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    USFDA