Events

Retiro De Equipo (Recall) de Electrical Power Cord

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 Stryker Endoscopy.

¿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
    56356
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0922-2011
  • Fecha de inicio del evento
    2010-04-16
  • Fecha de publicación del evento
    2011-01-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-01-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93289
  • 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
    Laparoscope, general &, plastic surgery - Product Code GCJ
  • Causa
    The electrical cord power plug design may allow the prongs to develop a fracture inside or outside the plug, if the plug is misused.
  • Acción
    Stryker Endoscopy sent an URGENT: Device Recall letter dated April 16, 2010, to Stryker Sales reps and all customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to: Locate the affected units. Visually inspect each cord for damage. If the cord has bent or cracked prongs the unit should be taken out of service immediately. The customer was instructed to call a Regulatory Affairs Recall Representative at (408) 754-2738 for further instruction. If the cord did not show signs of damage, it could remain in service. An acknowledgement form was included to document confirmation of receipt of the letter. Upon completion of the power cord inspection, customers were to sign the acknowledgement form indicating that all of their units were inspected. Customers were asked to mail the form to Stryker Endoscopy or fax to (408) 754-8378 or scan the card and email to PowerCord@stryker.com. For questions regarding this recall call the Stryker RA/QA Department at (408) 754-2738 or (800) 435-0220, Reference RA 2010-034.

Device

Electrical Power Cord
  • Modelo / Serial
    Model Numbers/First/Serial Numbers:  240-099-001, 240-099-001K; First Serial number: 070119AB001; 240-099-011, 240-099-011K; First Serial number :070112AD043; 240-099-020, 240-099-020K: First Serial number: 070123AG001 240-099-050; First Serial number: 061206AF001; 240-099-072; First Serial number: 081002AL001.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, ID, IL, IN, IA, KS, KY, LA, MA, ME, MI, MN, MS, MO, MT, NE, NH, NJ, NM, NV, MY, NC, ND, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY and the countries of Canada, Chile, China, India, Korea, Mexico, Singapore, Taiwan and Latin America.
  • Descripción del producto
    Stryker brand Cart with Isolation Transformer, || Model Numbers: 240-099-001, 240-099-001K, 240-099-011, 240-099-011K, 240-099-020, 240-099-020K, 240-099-050, 240-099-072. || 240-099-001, || 240-099-001K, || 240-099-011, || 240-099-011K, || 240-099-020, || 240-099-020K, || 240-099-050, || 240-099-072, || Product is manufactured and distributed by Stryker Endoscopy || San Jose, CA || The product is indicated for use in the carts include an isolation transfer and a power cord for connecting the transformer to an electrical outlet as means of providing power to the cart for the equipment it houses.
  • Manufacturer
    Stryker Endoscopy

Manufacturer

Stryker Endoscopy
  • Dirección del fabricante
    Stryker Endoscopy, 5900 Optical Ct, San Jose CA 95138-1400
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    USFDA