• Acerca de la base de datos
  • ¿Cómo usar la IMDD?
  • Descargar la data
  • Preguntas frecuentes
  • Créditos
Vista de la lista Vista de las tarjetas
  • Dispositivo 4
  • Fabricante 2
  • Evento 124969
  • Implante 0
Retiro De Equipo (Recall) de Integra Duragen Graft Matrix
  • Tipo de evento
    Recall
  • ID del evento
    14534
  • Fecha de inicio del evento
    2013-04-19
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Integra Neurosciences Pty Ltd (NZ), 5B Suite B, 331 Rosedale Road, Albany, Auckland 0632
  • Causa
    Specific lots of some collagen products may have deviated from a production process. the affected lots passed all product finished goods testing, are sterile, and were tested and accepted for endotoxin levels. however, due to a process deviation, they may have been released with higher levels of endotoxins that permitted by release specifications. higher endotoxin levels may result in fever in the immediate postoperative period. the manufacturer are not aware of any reports of patient injuries or other adverse events in connection with these product lots., the health hazard evaluation (hhe) provided by the manufacturer details that during an internal quality assurance review of processes, specific lots manufactured during the periods december 2010 to may 2011, and then december 2012 to february 2013, may possibly be affected.
  • Acción
    Product to be returned to supplier
Retiro De Equipo (Recall) de Integra Duragen Plus
  • Tipo de evento
    Recall
  • ID del evento
    14534
  • Fecha de inicio del evento
    2013-04-19
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Integra Neurosciences Pty Ltd (NZ), 5B Suite B, 331 Rosedale Road, Albany, Auckland 0632
  • Causa
    Specific lots of some collagen products may have deviated from a production process. the affected lots passed all product finished goods testing, are sterile, and were tested and accepted for endotoxin levels. however, due to a process deviation, they may have been released with higher levels of endotoxins that permitted by release specifications. higher endotoxin levels may result in fever in the immediate postoperative period. the manufacturer are not aware of any reports of patient injuries or other adverse events in connection with these product lots., the health hazard evaluation (hhe) provided by the manufacturer details that during an internal quality assurance review of processes, specific lots manufactured during the periods december 2010 to may 2011, and then december 2012 to february 2013, may possibly be affected.
  • Acción
    Product to be returned to supplier
Retiro De Equipo (Recall) de Well Lead OxyCap Adult CO2 Sampling Oxygen Mask
  • Tipo de evento
    Recall
  • ID del evento
    14543
  • Fecha de inicio del evento
    2013-04-22
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Device Technologies New Zealand, 47 Arrenway Drive, Albany, AUCKLAND 0632
  • Causa
    Identified that the tubing was not fitted correctly to the mask during production. this may result in malfuntioning during use, whereby if the tubing and masks connected bythe user is not firm enough, the tubing may come off during usage.
  • Acción
    Product to be returned to supplier
Retiro De Equipo (Recall) de Leica LPC Fine Mesh cassettes Pink
  • Tipo de evento
    Recall
  • ID del evento
    14544
  • Fecha de inicio del evento
    2013-04-23
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Leica BioSystems Melbourne Pty Ltd, 495 Blackburn Road, Mt Waverley, VIC 3149, AUSTRALIA
  • Causa
    Customer reported that during processing the tissue was lost. as a result patient required a rebiopsy. (see medsafe ref #14409)., latch on the cassette was broken.
  • Acción
    Product to be returned to supplier
Retiro De Equipo (Recall) de BBL DrySlide Kit
  • Tipo de evento
    Recall
  • ID del evento
    14555
  • Fecha de inicio del evento
    2013-04-23
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Becton Dickinson Ltd, 14B George Bourke Drive, Mt Wellington, Auckland 1060
  • Causa
    The dryslide oxidase is used for determining the oxidase reaction of bacteria., during the manufacturing process, portions of the test slides were placed into the incorrect product packaging. this could result in intermittent quality control and false results (the dryslide oxidase is used for determininh the oxidase reaction of bacteria).
  • Acción
    Product to be returned to supplier
Retiro De Equipo (Recall) de Device Recall Neonatal Total Galactose Test Kit
  • Tipo de evento
    Recall
  • ID del evento
    26412
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0969-03
  • Fecha de inicio del evento
    2003-05-30
  • Fecha de publicación del evento
    2003-07-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-10-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27639
  • 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
    Enzymatic Methods, Galactose - Product Code JIA
  • Causa
    The device is not stable throughout its labeled expiration date.
  • Acción
    The firm contacted their customers by telephone and facsimile on 5/30/2003.
Retiro De Equipo (Recall) de Panbio Dengue IgM Capture ELISA
  • Tipo de evento
    Recall
  • ID del evento
    14558
  • Fecha de inicio del evento
    2013-04-24
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Alere Ltd, C/- Bell Gully, Level 22, Vero Centre, 48 Shortland Street, AUCKLAND 1010
  • Causa
    Manufacturer's qa program has determined that a reassignment of a customer aceptance range is required for three lots of product. manufacturer received 5 complaints of invalid test runs due to results falling outside the cut-off value customer accetpance range leading to an invalid test. analysis has indicated that the invalid test runs are due to the customer acceptance range being inappropriately assigned for these batches.
  • Acción
    Instructions for use to be updated
Retiro De Equipo (Recall) de Terumo Trima Accel Automated Blood Collections System
  • Tipo de evento
    Recall
  • ID del evento
    14560
  • Fecha de inicio del evento
    2013-05-01
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: The Business Advisory Group Ltd, Level 13, 34 Shortland St, Auckland 1010
  • Causa
    Recall for product correction for the addition of a safety enhancement called air reduction mitigation (arm). this safety enhancement is being implemented to address the potential risk for air embolism should a donor be prematurely connected to the trimal accel system.
  • Acción
    Software to be upgraded
Retiro De Equipo (Recall) de Beckton Dickinson Vacutainer Multiple Sample Luer Adaptor
  • Tipo de evento
    Recall
  • ID del evento
    14561
  • Fecha de inicio del evento
    2013-04-26
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Becton Dickinson Ltd, 14B George Bourke Drive, Mt Wellington, Auckland 1060
  • Causa
    Manufacturer has received a number of complaints relating to blood leakage when the bd vacutainer multile sample luer adapter is used in the blood collection process. these complaints relate to:, 1. the sleeve covering the np cannula, 2.Luer tip damage., due to current stocks holdings both locally and globally and existing demands bd is unable to substitute product for the bd vacutainer multiple sample luer adapter. should a defective device be used bd is providing information (product correction ) regarding the use of the device ., bd recommends that staff closley observe the luer tip of the device for potential damage. in the event that damage is observed staff are instructed to discard the individual device. should blood leak from the luer connection during blood collection ases the need to conduct a re-draw with a new luer adaptor, based upn the volume of blood in the tube.
  • Acción
    Manufacturer to issue advice regarding use
Retiro De Equipo (Recall) de GE Healthcare Discovery MR450, MR750, MR750w and and Optima MR450w
  • Tipo de evento
    Recall
  • ID del evento
    14563
  • Fecha de inicio del evento
    2013-04-26
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: GE Healthcare Limited, 8 Tangihua Street, Auckland 1010
  • Causa
    Potential safety issue due to non-unique series identifiers embedded in image headers of certain ge mr products.
  • Acción
    Software to be upgraded
Retiro De Equipo (Recall) de Ethicon Electrosurgery Probe Plus II with Electrode
  • Tipo de evento
    Recall
  • ID del evento
    14564
  • Fecha de inicio del evento
    2013-04-26
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Johnson & Johnson Medical New Zealand Ltd, 507 Mt Wellington Highway, Mt Wellington, AUCKLAND 1060
  • Causa
    There is a potential for edge of the probe plus ii rotational knob to rub against the tyvek(r) and in remote instances puncture the tyvek(r) creating a pin hole. due to the possibility that a tear in the tyvek(r) packaging may compromise the sterility of the device the stated setrility levels could not be assured for the product. the endopath probe pluss ii shaft is sold and labelled as "sterile".
  • Acción
    Product to be returned to supplier
Alerta De Seguridad para Lifestyles Extra-Strength Condoms With Nonoxynol
  • Tipo de evento
    Safety alert
  • ID del evento
    ALERTA DIGEMID N° 11 - 2002
  • Fecha
    2002-10-03
  • País del evento
    Peru
  • Fuente del evento
    Digemid
  • URL de la fuente del evento
    http://www.digemid.minsa.gob.pe/UpLoad/UpLoaded/PDF/Alertas/2002/ALERTA_11-02.pdf
  • Notas / Alertas
    Peruvian data is current through August 2018. All of the data comes from Digemid, 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 Peru.
  • Notas adicionales en la data
  • Causa
    Nonoxinol-9 present.
Retiro De Equipo (Recall) de Ormco Orthodontic Respond Wire
  • Tipo de evento
    Recall
  • ID del evento
    14567
  • Fecha de inicio del evento
    2013-05-01
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Law and Accounting Professional Trustees Limited, 336, Jackson Street, Petone
  • Causa
    A customer complaint was received stating that the respond wire diameter description listed on the invoice did not match the descriptor listed on the packaging.
  • Acción
    Manufacturer to issue advice regarding use
Retiro De Equipo (Recall) de Roche Elecsys Beta CrossLaps Assay
  • Tipo de evento
    Recall
  • ID del evento
    14568
  • Fecha de inicio del evento
    2013-04-30
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Roche Diagnostics (NZ) Ltd, 15 Rakino Way, Mt Wellington, AUCKLAND 1644
  • Causa
    Sponsor has been informed of a change in sample stabiltity and biotin interference described in the elecsys beta crosslaps package insert.
  • Acción
    Manufacturer to issue advice regarding use
Retiro De Equipo (Recall) de Elekta Integrity 3.0
  • Tipo de evento
    Recall
  • ID del evento
    14569
  • Fecha de inicio del evento
    2013-04-29
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Elekta Pty Limited - New Zealand Branch, Level 2, Windsor Court , 128-136 Parnell Road, Parnell, AUCKLAND 1052
  • Causa
    During beam delivery, the tolerance values are used to do a check for unwanted movements. these values are known as "static tolerances" which are related to all the digital accelerator geometric movement axes except table column. the problem is that the "static tolerances" from the calibration files (loaded database) are used for beam delivery instead of the machine calculated values. a fault occurs if the loaded database is incorrect.
  • Acción
    Software to be upgraded
Retiro De Equipo (Recall) de Varian RPM Respiratory Gating System
  • Tipo de evento
    Recall
  • ID del evento
    14570
  • Fecha de inicio del evento
    2013-04-29
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Varian Medical Systems Australasia Pty Ltd (NZ), C/- BDO Auckland - Christine Koefoed, Level 4, BDO Centre, 4 Graham Street, Auckland 1140
  • Causa
    Manufacturer has identified an anomaly with the rpm respiratory gating system. while operating with the 6-dot marker block, this version of the rpm gating may produce an inverted respiratory waveform in amplitude and phase-gating sessions., the error may be reproduced if the rpm system is induced to frequently lose and re-acquire tracking of the 6-door marker block during a calibration sequence, a reference session or a single session after tracking has begun.
  • Acción
    Software to be upgraded
Retiro De Equipo (Recall) de Abbott Architect STAT High Sensitive Tromponin-I Controls
  • Tipo de evento
    Recall
  • ID del evento
    14571
  • Fecha de inicio del evento
    2013-04-29
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Abbott Diagnostics Division, Ground Floor, Building D, 4 Pacific Rise, Mt Wellington, AUCKLAND 1640
  • Causa
    During internal studies it was noted that architect stat high sensitive troponin-i calibrators and controls may decline in performance prior to their defined expiration notes.
  • Acción
    Manufacturer to issue advice regarding use
Retiro De Equipo (Recall) de Abbott Architect STAT High Sensitive Troponin-I Calibrators
  • Tipo de evento
    Recall
  • ID del evento
    14571
  • Fecha de inicio del evento
    2013-04-29
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Abbott Diagnostics Division, Ground Floor, Building D, 4 Pacific Rise, Mt Wellington, AUCKLAND 1640
  • Causa
    During internal studies it was noted that architect stat high sensitive troponin-i calibrators and controls may decline in performance prior to their defined expiration notes.
  • Acción
    Manufacturer to issue advice regarding use
Retiro De Equipo (Recall) de GE LOGIQ S8 and LOQIQ S7 Ultrasound
  • Tipo de evento
    Recall
  • ID del evento
    14572
  • Fecha de inicio del evento
    2013-04-30
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: GE Healthcare Limited, 8 Tangihua Street, Auckland 1010
  • Causa
    Manufacturer has recently become aware of a potential safety issue due to the s4-10-d ultrasound probe used in conjunction with the logiq s8 and logiq s7 ultrasound systems. it was also discovered that this issue also leads to a specification issue of the acoustic output of this probe, there is a potential for a skin burn when the flow model in the cardiac application is activated with the s4-10-d ultrasound probe.
  • Acción
    Software to be upgraded
Retiro De Equipo (Recall) de Masimo Rad-8 Pulse Oximeters
  • Tipo de evento
    Recall
  • ID del evento
    14582
  • Fecha de inicio del evento
    2013-05-02
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Promed Technologies Ltd, Unit B, 14-22 Triton Drive, Upper Harbour, North Shore, Auckland 0632
  • Causa
    Manufacturer has identified a very small number of rad-8 devices that when moved can power off without the operator pressing the power button. if a change in power status goes unnoticed then a delay of care could result.
  • Acción
    Product to be modified
Retiro De Equipo (Recall) de FlexStent Femoropopliteal Self-Exanding Stent System
  • Tipo de evento
    Recall
  • ID del evento
    14584
  • Fecha de inicio del evento
    2013-05-02
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Endoventure Ltd, 2/1 Esmonde Road, Takapuna, Auckland
  • Causa
    Manufacturer has determined that during internal package integrity testing, following transportation simulation challenge, the sterile barrrier of the pouch (inner pouch) of some units of the flexistent could be compromised.And to a lesser degree, the outer pouch., to date no complaints associated with this potential mode of failure have been reported., in the event a hole or a tear in the clear film side of the pouch of the affected product is present and both pouches are affected, loss of the sterile barrier could occur, leading to use of a non-sterile device in the procedure.
  • Acción
    Product to be returned to supplier
Retiro De Equipo (Recall) de Ethicon LIGACLIP Endoscopic Rotating Multiple Clip Applier
  • Tipo de evento
    Recall
  • ID del evento
    14586
  • Fecha de inicio del evento
    2013-05-02
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Johnson & Johnson Medical New Zealand Ltd, 507 Mt Wellington Highway, Mt Wellington, AUCKLAND 1060
  • Causa
    Potential clip formation and feeding issues which may result in improper clip formation, vessel damage and/ or insuffcient occlusion of the vessel or other structure.
  • Acción
    Product to be returned to supplier
Retiro De Equipo (Recall) de Hologic Mini C-arm
  • Tipo de evento
    Recall
  • ID del evento
    14588
  • Fecha de inicio del evento
    2013-06-06
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Pharmaco (NZ) Ltd, Level 1, 4 Fisher Crescent, Mt Wellington, AUCKLAND 1060
  • Causa
    Manufacturer has identified the following compliance issues:, 1.The audible alarm to alert the operator when cumulative irradiation time reaches five minutes is not accurate., 2. the total cumulative irradiation time display is not accuarate., both issues are caused by computational error which truncates the fractions of seconds after each image and therefore the time to alarm and the time displayed are shorter by the sum of these fractions., this non-compliance does not pose a health hazard, as the radiation exposure to a patient depends on power settings during the procedure. the system provides the user with accurate dose to the patient information by displaying air kerma and cumulative air kerma.
  • Acción
    Software to be upgraded
Retiro De Equipo (Recall) de HemoCue HbA1c 501 Test Cartridge
  • Tipo de evento
    Recall
  • ID del evento
    19409
  • Fecha de inicio del evento
    2015-11-20
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Radiometer Pacific, Unit 3, 33 Spartan Road, Takanini 2105
  • Causa
    The manufacturer has identified that some of the hba1c501 test cartridges, lot f14k12k21dl, may give elevated results.
  • Acción
    Product to be destroyed
Retiro De Equipo (Recall) de Hospira Suction Canister
  • Tipo de evento
    Recall
  • ID del evento
    14590
  • Fecha de inicio del evento
    2013-05-07
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
    ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
  • Notas adicionales en la data
    Recalling Organisation: Hospira NZ Ltd, 58 Richard Pearse Drive, Airport Oaks, Mangere, Auckland 2022
  • Causa
    Medical device alert issued due to the potential failure or loss of suction of receptal 1 litre suction canisters and liners manufactured by hospira.
  • Acción
    Product to be returned to supplier
  • 1
  • 2
  • 3
  • …
  • Next ›
  • Last »

Acerca de la base de datos

Explore más de 120,000 registros de retiros, alertas y notificaciones de seguridad de dispositivos médicos y sus conexiones con los fabricantes.

  • Preguntas frecuentes
  • Acerca de la base de datos
  • Contáctenos
  • Créditos

Historias en su correo

¿Trabaja en la industria médica? ¿O tiene experiencia con algún dispositivo médico? Nuestra reportería no ha terminado. Queremos oír de usted.

¡Cuéntanos tu historia!

Aviso

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.

Descargar la data

La International Medical Devices Database está bajo la licencia Open Database License y sus contenidos bajo la licencia Creative Commons Attribution-ShareAlike . Al usar esta data, siempre citar al International Consortium of Investigative Journalists. Puede descargar acá una copia de la base de datos.

Descargar todo (zipped)