Events

Retiro De Equipo (Recall) de Device Recall Philips brand BrightView Gamma Camera System, SYST, BRIGHTVIEWFIXED, 3/8"

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.

¿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
    59077
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2867-2011
  • Fecha de inicio del evento
    2011-06-03
  • Fecha de publicación del evento
    2011-07-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-11-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=101026
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Notas adicionales en la data
    System, tomography, computed, emission - Product Code -KPS
  • Causa
    The gap between the two parts of the table may permit pinches to occur on either patients skin or other body parts; it has the potential for serious injury if a patients finger is caught between the pallet and patient table resulting in broken finger bone.
  • Acción
    Philips Healthcare issued a Customer Information letter (Field Change Order (#88200402)) dated June 15, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to follow the instruction for use for their system, which states "Monitor the patient and the system vigilantly during any system motions to make sure that ...accessories, equipment, and all ojbects such as hair, jewelry, or neckties-remain clear of any moving camera and imaging table parts. For additional information, customers were istructed to see the BrightView SPECT instructions for Use, section 2.2 - Safety Warnings and Precautions and Safety and Information Labels. Philips Healthcare will notify all affected customers and will install a sticker through an Action for Performance - Proactive Field Change Order (FCO) to resolve the issue. For customers in North America who require further information or support contact Customer Care Solutions Center at 1-800-722-9377, Select Option 5. In all other countries the local Philips Healthcare office should be contacted.

Device

Device Recall Philips brand BrightView Gamma Camera System, SYST, BRIGHTVIEWFIXED, 3/8"
  • Modelo / Serial
    System Code: 882480;  Serial #s: 4000224, 4000061, 4000321, 4000043, 4000065, 4000081, 4000180, 4000044, 4000527, 4000298, 4000229, 4000262, 4000378, 4000280, 4000336, 4000324, 4000184, 4000190, 4000516, 4000303, 4000411, 4000305, 4000009, 4000012, 4000413, 4000213, 4000335, 4000436, 4000500, 4000491, 4000510, 4000518, 4000418, 4000454, 4000197, 4000353, 4000469, 4000005, 4000042, 4000379, 4000533, 4000451, 4000137, 4000343, 4000030, 4000540, 4000421, 4000342, 4000495, 4000511, 4000317, 4000338, 4000316, 4000408, 4000251, 4000031, 4000341, 4000122, 4000530, 4000395, 4000286, 4000294, 4000348, 4000296, 4000462, 4000463, 4000464, 4000419, 4000096, 4000476, 4340005, 4000484, 4000268, 4000382, 4000169, 4000447, 4000228, 4000442, 4000297, 4000047, 4000049, 4000488, 4000156, 4000412, 4000273, 4000337, 4000394, 4000194, 4000179, 4000401, 4000385, 4000504, 4000121, 4000109, 4000115, 4000257, 4000503, 4000105, 4000356, 4000333, 4000339, 4000107, 4000227, 4000233, 4000173, 4000400, 4000397, 4000398, 4000494, 4000256, 4000386, 4000168, 4000126, 4000154, 4000399, 4000272, 4000478, 4340004, 4000219, 4000243, 4000437, 4000376, 4000416, 4000485, 4000035, 4000515, 4000427, 4000142, 4000226, 4000519, 4000475 4000066, 4000183, 4000459, 4000461, 4000468, 4000210, 4000063 4000150, 4000217, 4000393, 4000420, 4000479, 4000300, 4000075, 4000080, 4000086, 4000013, 4000396, 4000481, 4000392, 4000157, 4000323, 4000374, 4000072, 4000237, 4000493, 4000354, 4000203, 4000167, 4000041, 4000407, 4000372, 4000133, 4000209, 4000299, 4000477, 4000314, 4000010, 4000539, 4000409, 4000134, 4000153, 4000373, 4000471, 4000163, 4000465, 4000082, 4000331, 4000282, 4000449, 4000216, 4000269, 4000415, 4000345, 4000208, 4000279, 4000254, 4000125, 4000201,
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) and Puerto Rico and the countries of Australia, Austria, Bahrain, Belgium, Brazil, China, Chile, Columbia, Czech Republic, Denmark, Dominican Republic, Egypt, France, Greece, India, Iran, Israel, Italy, Japan, Lithuania, Malaysia, Mexico, Netherlands, Peru, Portugal, Russia, Saudi Arabia, Singapore, South Korea, Spain, Switxerland, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, and the United Kingdom.
  • Descripción del producto
    Philips brand BrightView Gamma Camera System, || SYST, BRIGHTVIEW-FIXED, 3/8", Model Number: 4535-602-79781; || Product is manufactured and distributed by || Philips Medical Systems (Cleveland), Inc., || Cleveland, OH || The BrightView Gamma Camera System is intended to produce images depicting the anatomical distributions of single photon emitting radioisotopes within the human body for interpretation by medical personnel
  • Manufacturer
    Philips Medical Systems

Manufacturer

Philips Medical Systems
  • Dirección del fabricante
    Philips Medical Systems, 3860 N 1st St, San Jose CA 95134-1702
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    USFDA