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  • Dispositivo 72
  • Fabricante 72
  • Evento 73
  • Implante 0
Retiro De Equipo O Alerta De Seguridad para STERRAD 50 Sterilizer
  • Tipo de evento
    Recall / Safety alert
  • País del evento
    Malaysia
  • Fuente del evento
    MHM
  • URL de la fuente del evento
    https://portal.mda.gov.my/
  • Notas / Alertas
    Malaysian data is current through October 2018. All of the data comes from the Ministry of Health Malaysia, except for the categories Manufacturer Parent Company and Product Classification.
    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, based on matches of recall data from the U.S. and Malaysia.
  • Notas adicionales en la data
    ALERT- PRODUCT CORRECTIONProduct: spesific STERRAD 50 SterilizerRead More:1. Alert Letter from MDB2. Johnson & Johnson's Letter to MDB 3. Johnson & Johnson's Customer Notification Letter
Retiro De Equipo O Alerta De Seguridad para MEDTRONICS Dual Chambers Pacemaker
  • Tipo de evento
    Recall / Safety alert
  • Fecha
    2011-04-20
  • País del evento
    Malaysia
  • Fuente del evento
    MHM
  • URL de la fuente del evento
    https://portal.mda.gov.my/
  • Notas / Alertas
    Malaysian data is current through October 2018. All of the data comes from the Ministry of Health Malaysia, except for the categories Manufacturer Parent Company and Product Classification.
    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, based on matches of recall data from the U.S. and Malaysia.
  • Notas adicionales en la data
    ALERT: MEDTRONICS Dual Chambers Pacemaker1. Letter from MDB 2. Letter from Medtronic
Retiro De Equipo O Alerta De Seguridad para THERMO SCIENTIFIC HM355S-31
  • Tipo de evento
    Recall / Safety alert
  • País del evento
    Malaysia
  • Fuente del evento
    MHM
  • URL de la fuente del evento
    https://portal.mda.gov.my/
  • Notas / Alertas
    Malaysian data is current through October 2018. All of the data comes from the Ministry of Health Malaysia, except for the categories Manufacturer Parent Company and Product Classification.
    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, based on matches of recall data from the U.S. and Malaysia.
  • Notas adicionales en la data
    ALERT: Thermo Fisher Scientific’s – THERMO SCIENTIFIC HM355S-31. Letter from MDCD 2. Direct Customer letter 3. Distributor letter 4. FSCA MY 5. Unit list-HM355S
Retiro De Equipo O Alerta De Seguridad para Gambro and Hospal blood sets (lot numbers 0806 –0817)
  • Tipo de evento
    Recall / Safety alert
  • Número del evento
    MDB/A/2008/007
  • Fecha
    2008-07-10
  • País del evento
    Malaysia
  • Fuente del evento
    MHM
  • URL de la fuente del evento
    https://portal.mda.gov.my/
  • Notas / Alertas
    Malaysian data is current through October 2018. All of the data comes from the Ministry of Health Malaysia, except for the categories Manufacturer Parent Company and Product Classification.
    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, based on matches of recall data from the U.S. and Malaysia.
  • Notas adicionales en la data
    MDB/A/2008/007 -  Gambro has identified the potential for a total or partial occlusion of the arterial (red) and/or venous (blue) dialyser connectors of these blood tubing sets.   This is due to a moulding defect.Read more.
Retiro De Equipo O Alerta De Seguridad para LIFEPAK 15 Monitor/Defibrillator
  • Tipo de evento
    Recall / Safety alert
  • País del evento
    Malaysia
  • Fuente del evento
    MHM
  • URL de la fuente del evento
    https://portal.mda.gov.my/
  • Notas / Alertas
    Malaysian data is current through October 2018. All of the data comes from the Ministry of Health Malaysia, except for the categories Manufacturer Parent Company and Product Classification.
    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, based on matches of recall data from the U.S. and Malaysia.
  • Notas adicionales en la data
    ALERT: Limited number of LIFEPAK 15 Monitor/Defibrillator1. Letter from MDB 2. Letter from Medtronic
Retiro De Equipo O Alerta De Seguridad para MODEL 5388 DUAL CHAMBER EXTERNAL TEMPORARY PULSE GENE...
  • Tipo de evento
    Recall / Safety alert
  • País del evento
    Malaysia
  • Fuente del evento
    MHM
  • URL de la fuente del evento
    https://portal.mda.gov.my/
  • Notas / Alertas
    Malaysian data is current through October 2018. All of the data comes from the Ministry of Health Malaysia, except for the categories Manufacturer Parent Company and Product Classification.
    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, based on matches of recall data from the U.S. and Malaysia.
  • Notas adicionales en la data
    ALERT: MODEL 5388 DUAL CHAMBER EXTERNAL TEMPORARY PULSE GENERATOR1. Letter from MDB 2. Letter from Medtronic
Retiro De Equipo O Alerta De Seguridad para Omnifuse and Omnifuse PCA Syringe Pumps
  • Tipo de evento
    Recall / Safety alert
  • País del evento
    Malaysia
  • Fuente del evento
    MHM
  • URL de la fuente del evento
    https://portal.mda.gov.my/
  • Notas / Alertas
    Malaysian data is current through October 2018. All of the data comes from the Ministry of Health Malaysia, except for the categories Manufacturer Parent Company and Product Classification.
    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, based on matches of recall data from the U.S. and Malaysia.
  • Notas adicionales en la data
    Alert: Omnifuse and Omnifuse PCA Syringe Pumps (“Omnifuse Pumps”)1. Letter from MDB 2. Customer Information Bulletin 2015 3. Field Safety Notice 4. MEDDEV FSCA Report Form 5. Response Form 6. Risk Review Analysis Summary
Retiro De Equipo O Alerta De Seguridad para CONSULTA CRT-D, SECURA DR/VR, CONCERTO II CRT-D, VIRT...
  • Tipo de evento
    Recall / Safety alert
  • País del evento
    Malaysia
  • Fuente del evento
    MHM
  • URL de la fuente del evento
    https://portal.mda.gov.my/
  • Notas / Alertas
    Malaysian data is current through October 2018. All of the data comes from the Ministry of Health Malaysia, except for the categories Manufacturer Parent Company and Product Classification.
    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, based on matches of recall data from the U.S. and Malaysia.
  • Notas adicionales en la data
    ALERT: CONSULTA CRT-D, SECURA DR/VR, CONCERTO II CRT-D, VIRTUOSO II DR/VR, MAXIMO II CRT-D, MAXIMO I1. MDB Alert2. Letter from Medtronic
Retiro De Equipo O Alerta De Seguridad para Baxter Infusor - Product Codes: 2C1008KP, 2C1009KP
  • Tipo de evento
    Recall / Safety alert
  • Fecha
    2009-09-07
  • País del evento
    Malaysia
  • Fuente del evento
    MHM
  • URL de la fuente del evento
    https://portal.mda.gov.my/
  • Notas / Alertas
    Malaysian data is current through October 2018. All of the data comes from the Ministry of Health Malaysia, except for the categories Manufacturer Parent Company and Product Classification.
    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, based on matches of recall data from the U.S. and Malaysia.
  • Notas adicionales en la data
    ALERT : Baxter Infusor - Product Codes: 2C1008KP, 2C1009KP - Multiple lots affected.1. MDB Alert Letter2. Baxter's Letter3. Product Brochure
Retiro De Equipo O Alerta De Seguridad para Deep Brain Stimulation Lead Kits Model 3387, 3387S, 3...
  • Tipo de evento
    Recall / Safety alert
  • Número del evento
    MDB/A/2008/013
  • Fecha
    2008-08-22
  • País del evento
    Malaysia
  • Fuente del evento
    MHM
  • URL de la fuente del evento
    https://portal.mda.gov.my/
  • Notas / Alertas
    Malaysian data is current through October 2018. All of the data comes from the Ministry of Health Malaysia, except for the categories Manufacturer Parent Company and Product Classification.
    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, based on matches of recall data from the U.S. and Malaysia.
  • Notas adicionales en la data
    MDB/A/2008/013  -  Deep Brain Stimulation Lead Kits Model 3387, 3387S, 3389 and 3389S DBS Lead Kits.  Field Corrective Action letter dated 15 August 2008 from Medtronic International Ltd.Read more.
Retiro De Equipo O Alerta De Seguridad para LIFEPAK 20 AND LIFEPAK 20e DEFIBRILLATORS/MONITORS
  • Tipo de evento
    Recall / Safety alert
  • País del evento
    Malaysia
  • Fuente del evento
    MHM
  • URL de la fuente del evento
    https://portal.mda.gov.my/
  • Notas / Alertas
    Malaysian data is current through October 2018. All of the data comes from the Ministry of Health Malaysia, except for the categories Manufacturer Parent Company and Product Classification.
    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, based on matches of recall data from the U.S. and Malaysia.
  • Notas adicionales en la data
    ALERT: LIFEPAK 20 AND LIFEPAK 20e DEFIBRILLATORS/MONITORS1. MDB's Alert 2. Letter form Medtronic
Retiro De Equipo O Alerta De Seguridad para EnRhythm Pacemakers
  • Tipo de evento
    Recall / Safety alert
  • Fecha
    2010-03-02
  • País del evento
    Malaysia
  • Fuente del evento
    MHM
  • URL de la fuente del evento
    https://portal.mda.gov.my/
  • Notas / Alertas
    Malaysian data is current through October 2018. All of the data comes from the Ministry of Health Malaysia, except for the categories Manufacturer Parent Company and Product Classification.
    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, based on matches of recall data from the U.S. and Malaysia.
  • Notas adicionales en la data
    ALERT: EnRhythm Pacemakers1. Letter from MDB 2.  Letter from Medtronic International
Retiro De Equipo O Alerta De Seguridad para HomeChoice Automated PD System and HomeChoice PRO Aut...
  • Tipo de evento
    Recall / Safety alert
  • País del evento
    Malaysia
  • Fuente del evento
    MHM
  • URL de la fuente del evento
    https://portal.mda.gov.my/
  • Notas / Alertas
    Malaysian data is current through October 2018. All of the data comes from the Ministry of Health Malaysia, except for the categories Manufacturer Parent Company and Product Classification.
    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, based on matches of recall data from the U.S. and Malaysia.
  • Notas adicionales en la data
    ALERT: HomeChoice Automated PD System and HomeChoice PRO Automated PD SystemProduct Codes: 5C4474 and R5C83201. Letter from MDB 2. Letter from Baxter 1 3. Letter from Baxter 2
Retiro De Equipo O Alerta De Seguridad para CORDIS Cypher Select + Sirolimus-eluting Coronary Stent
  • Tipo de evento
    Recall / Safety alert
  • País del evento
    Malaysia
  • Fuente del evento
    MHM
  • URL de la fuente del evento
    https://portal.mda.gov.my/
  • Notas / Alertas
    Malaysian data is current through October 2018. All of the data comes from the Ministry of Health Malaysia, except for the categories Manufacturer Parent Company and Product Classification.
    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, based on matches of recall data from the U.S. and Malaysia.
  • Notas adicionales en la data
    ALERT: CORDIS Cypher Select + Sirolimus-eluting Coronary Stent.1. Letter from MDB 2. Letter from Johnson & Johnson
Retiro De Equipo O Alerta De Seguridad para Homechoice / Homechoice Pro Automated Peritoneal Dial...
  • Tipo de evento
    Recall / Safety alert
  • Número del evento
    MDB/A/2008/003
  • Fecha
    2008-05-20
  • País del evento
    Malaysia
  • Fuente del evento
    MHM
  • URL de la fuente del evento
    https://portal.mda.gov.my/
  • Notas / Alertas
    Malaysian data is current through October 2018. All of the data comes from the Ministry of Health Malaysia, except for the categories Manufacturer Parent Company and Product Classification.
    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, based on matches of recall data from the U.S. and Malaysia.
  • Notas adicionales en la data
    MDB/A/2008/003 - Homechoice / Homechoice Pro Automated Peritoneal Dialysis System - current software versions by Baxter Internationals.  The company has received a report of dehydration occurring in a pediatric patient, where patient received incorrect amount of dextrose (with different concentration).Read more.
Retiro De Equipo O Alerta De Seguridad para NIKKISO AQUARIUS SYSTEM – MACHINE’S WHEEL – AQUARIUS...
  • Tipo de evento
    Recall / Safety alert
  • País del evento
    Malaysia
  • Fuente del evento
    MHM
  • URL de la fuente del evento
    https://portal.mda.gov.my/
  • Notas / Alertas
    Malaysian data is current through October 2018. All of the data comes from the Ministry of Health Malaysia, except for the categories Manufacturer Parent Company and Product Classification.
    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, based on matches of recall data from the U.S. and Malaysia.
  • Notas adicionales en la data
    ALERT: NIKKISO AQUARIUS SYSTEM – MACHINE’S WHEEL –  AQUARIUS HEMOFILTRATION DEVICE1. Letter from MDB 2. Letter from Nikkiso 3. Letter from Baxter to Medical Device Control Division 4. Letter from Baxter
Retiro De Equipo O Alerta De Seguridad para Hospira butterfly winged needle infusion set
  • Tipo de evento
    Recall / Safety alert
  • Número del evento
    MDB/A/2008/001
  • Fecha
    2008-05-07
  • País del evento
    Malaysia
  • Fuente del evento
    MHM
  • URL de la fuente del evento
    https://portal.mda.gov.my/
  • Notas / Alertas
    Malaysian data is current through October 2018. All of the data comes from the Ministry of Health Malaysia, except for the categories Manufacturer Parent Company and Product Classification.
    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, based on matches of recall data from the U.S. and Malaysia.
  • Notas adicionales en la data
    MDB/A/2008/001 - Hospira butterfly winged needle infusion set  -  regular and intermittent.  All batches manufactured prior to April 2008. Read more.
Retiro De Equipo O Alerta De Seguridad para All TomoTherapy Hi-ART Systems – with Version 3.x and...
  • Tipo de evento
    Recall / Safety alert
  • Fecha
    2010-05-03
  • País del evento
    Malaysia
  • Fuente del evento
    MHM
  • URL de la fuente del evento
    https://portal.mda.gov.my/
  • Notas / Alertas
    Malaysian data is current through October 2018. All of the data comes from the Ministry of Health Malaysia, except for the categories Manufacturer Parent Company and Product Classification.
    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, based on matches of recall data from the U.S. and Malaysia.
  • Notas adicionales en la data
    ALERT : All TomoTherapy Hi-ART Systems – with Version 3.x and 4.0.x software1. Letter from MDB 2. Letter from TomoTherapy [LETTER 1 ]  [LETTER 2 ]  [LETTER 3 ]
Retiro De Equipo O Alerta De Seguridad para Invasive blood pressure monitoring sets: LogiCal, Nov...
  • Tipo de evento
    Recall / Safety alert
  • Número del evento
    MDB/A/2008/005
  • Fecha
    2008-06-20
  • País del evento
    Malaysia
  • Fuente del evento
    MHM
  • URL de la fuente del evento
    https://portal.mda.gov.my/
  • Notas / Alertas
    Malaysian data is current through October 2018. All of the data comes from the Ministry of Health Malaysia, except for the categories Manufacturer Parent Company and Product Classification.
    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, based on matches of recall data from the U.S. and Malaysia.
  • Notas adicionales en la data
    MDB/A/2008/005 - Invasive blood pressure monitoring sets: LogiCal, NovaTrans and TransStar models with trigger flush device.  These devices are disposable blood pressure monitoring sets with a trigger flush device to maintain patency of the line during invasive pressure monitoring.Read more.
Retiro De Equipo O Alerta De Seguridad para TomoDirect Delivery licensed systems
  • Tipo de evento
    Recall / Safety alert
  • Fecha
    2010-11-15
  • País del evento
    Malaysia
  • Fuente del evento
    MHM
  • URL de la fuente del evento
    https://portal.mda.gov.my/
  • Notas / Alertas
    Malaysian data is current through October 2018. All of the data comes from the Ministry of Health Malaysia, except for the categories Manufacturer Parent Company and Product Classification.
    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, based on matches of recall data from the U.S. and Malaysia.
  • Notas adicionales en la data
    ALERT: All TomoDirect Delivery licensed systems1. Letter from MDB 2.TomoTherapy Inc
Retiro De Equipo O Alerta De Seguridad para Lifepak 12 and Lifepak 20/20e Defibrillators/Monitors
  • Tipo de evento
    Recall / Safety alert
  • Número del evento
    MDB/A/2008/004
  • Fecha
    2008-06-03
  • País del evento
    Malaysia
  • Fuente del evento
    MHM
  • URL de la fuente del evento
    https://portal.mda.gov.my/
  • Notas / Alertas
    Malaysian data is current through October 2018. All of the data comes from the Ministry of Health Malaysia, except for the categories Manufacturer Parent Company and Product Classification.
    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, based on matches of recall data from the U.S. and Malaysia.
  • Notas adicionales en la data
    MDB/A/2008/004 - Lifepak 12 and Lifepak 20/20e Defibrillators/Monitors by Medtronics.  Field corrective action due to some of the above models have a potential to incorrectly render a shock or no shock decision during automated external defibrillators (AED) analysis.Read more.
Retiro De Equipo O Alerta De Seguridad para Omnifuse and Omnifuse PCA syringe pumps
  • Tipo de evento
    Recall / Safety alert
  • Número del evento
    MDB/A/2008/010
  • Fecha
    2008-07-23
  • País del evento
    Malaysia
  • Fuente del evento
    MHM
  • URL de la fuente del evento
    https://portal.mda.gov.my/
  • Notas / Alertas
    Malaysian data is current through October 2018. All of the data comes from the Ministry of Health Malaysia, except for the categories Manufacturer Parent Company and Product Classification.
    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, based on matches of recall data from the U.S. and Malaysia.
  • Notas adicionales en la data
    MDB/A/2008/010  -  Smiths Medical Graseby Omnifuse and Omnifuse PCA syringe pumps.  Possibility of patients being given an additional / unnecessary infusion when syringes are changed or infusion restarted when using DrugPro software.Read more.
Retiro De Equipo O Alerta De Seguridad para Reagent Red Blood Cells (RRBC)
  • Tipo de evento
    Recall / Safety alert
  • País del evento
    Malaysia
  • Fuente del evento
    MHM
  • URL de la fuente del evento
    https://portal.mda.gov.my/
  • Notas / Alertas
    Malaysian data is current through October 2018. All of the data comes from the Ministry of Health Malaysia, except for the categories Manufacturer Parent Company and Product Classification.
    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, based on matches of recall data from the U.S. and Malaysia.
  • Notas adicionales en la data
    ALERT: Discolouration and Haemolysis of 0.8% RRBCproducts: (certain number of products within the indicated batch)- not all kits are affected.Abtectcell III 0.8%Phenocell C 0.8%1. Letter from MDB 2. Letter from CSL [Page 1 ] [Page 2 ]
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Los dispositivos médicos ayudan con el diagnóstico, la prevención y el tratamiento de muchas lesiones y enfermedades. A través de la International Medical Devices Database no estamos sugiriendo que compañías u otras entidades mencionadas en la base de datos hayan sido parte de una conducta ilegal o hayan actuado de manera impropia. Un mismo dispositivo médico puede tener distintos nombres en diferentes países. Esta base de datos no busca proporcionar asesoría médica. Los pacientes deben consultar con sus médicos para determinar si la data contiene información relevante y si la misma tiene implicaciones médicas para ellos.