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  • Dispositivo 84
  • Fabricante 28
  • Evento 124969
  • Implante 0
Retiro De Equipo (Recall) de Siemens ADVIA Centaur Systems TSH3 Ultra 100T, 500T
  • Tipo de evento
    Recall
  • ID del evento
    16546
  • Fecha de inicio del evento
    2014-04-15
  • 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: Siemens Healthcare (NZ) Ltd, Millennium Centre, Part Level 2, Building A, 600 Great South Road, Ellerslie, AUCKLAND 1051
  • Causa
    Manufacturer confirmed that samples containing fluoroscein may show inteference with the advia centaur systems tsh3 ultra, vitamin d and the advia centaur brahms procalcitonin assays.
  • Acción
    Instructions for use to be updated
Retiro De Equipo (Recall) de Siemens ADVIA Centaur Systems VitD 100T, 500T
  • Tipo de evento
    Recall
  • ID del evento
    16546
  • Fecha de inicio del evento
    2014-04-15
  • 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: Siemens Healthcare (NZ) Ltd, Millennium Centre, Part Level 2, Building A, 600 Great South Road, Ellerslie, AUCKLAND 1051
  • Causa
    Manufacturer confirmed that samples containing fluoroscein may show inteference with the advia centaur systems tsh3 ultra, vitamin d and the advia centaur brahms procalcitonin assays.
  • Acción
    Instructions for use to be updated
Retiro De Equipo (Recall) de Baxter FOLFusor SV 0.5ml/hr
  • Tipo de evento
    Recall
  • ID del evento
    16552
  • Fecha de inicio del evento
    2014-04-17
  • 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: Baxter Healthcare Ltd, 33 Vestey Drive, Mt Wellington, AUCKLAND
  • Causa
    Manufacturer has continued to investigate complaints for over-infusion and wants to make customers aware that the direction insert states that infusion rates may be up to 10% greater than the nominal (labeled) infusion rate of 0.5ml/hr. recent review of flow rate testing indicates that infusion rates may be higher and could result in a 15% greater than nominal (labeled) infusion rate., baxter is considering options to bring the flow rate into alignment with curent labeling.
  • Acción
    Instructions for use to be updated
Retiro De Equipo (Recall) de Baxter Colied Tube INFUSOR System cs
  • Tipo de evento
    Recall
  • ID del evento
    16553
  • Fecha de inicio del evento
    2014-04-17
  • 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: Baxter Healthcare Ltd, 33 Vestey Drive, Mt Wellington, AUCKLAND
  • Causa
    Manufacturer has received complaints for infusion flow rates greater than intended for the listed portable elastomeric infusion systems. manufacturer is requesting that healtrhcare providers consider the instructions for use which explain facts that may impact resulting flow rate., point #5 of the instructions for use is incorrect and manufactrer will be making a change to this to reflect this information.
  • Acción
    Instructions for use to be updated
Retiro De Equipo (Recall) de Cochlear Soft Tissue Gauge
  • Tipo de evento
    Recall
  • ID del evento
    16554
  • Fecha de inicio del evento
    2014-04-17
  • 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: Cochlear NZ Limited, C/- KPMG, 18 Viaduct Harbour Ave, Auckland 1010
  • Causa
    Manufacturer informed of a potential quality issue with the product. a health risk assessment was performed and the following potential risks were identified:, 1. metal fragement comes loose and ends up on/ under the patient's skin during surgery casuing an inflammatory response, 2. endotocins lefton instrument after cleaning and sterilisation, 3.Metal fragment/ sharp edge (causing additional scratches to soft tissue during surgery.).
  • Acción
    Product to be destroyed
Retiro De Equipo (Recall) de Otto Bock A200 Power Wheelchair, Skippi and Skippi Plus Power Wheelc...
  • Tipo de evento
    Recall
  • ID del evento
    16556
  • Fecha de inicio del evento
    2014-04-23
  • 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: Allied Medical Ltd, 29 Triton Drive, North Harbour, Auckland
  • Causa
    During the course of on-going market observations it was noticed that the complaint rate for the front caster forks on the three power wheelchairs had increased. the caster forks may in unusual circumstances break.
  • Acción
    Product to be returned to supplier
Retiro De Equipo (Recall) de Siemens Digital Linear Accelerator PRIMUS, ONCOR and ARTISTE 550TxT ...
  • Tipo de evento
    Recall
  • ID del evento
    16558
  • Fecha de inicio del evento
    2014-04-17
  • 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: Siemens Healthcare (NZ) Ltd, Millennium Centre, Part Level 2, Building A, 600 Great South Road, Ellerslie, AUCKLAND 1051
  • Causa
    1. in very rare instances the actual table position maysignificantly deviate from the position at the table side control and the linac control console, but no interlock occurs., 2. in sporadic cases the following issue for the table axis lateral, longitudinal and isocentric rotation occurs: after a manual table movement with released brake an immediate automatic movement for the same trable axis is not possible.
  • Acción
    Software to be upgraded
Retiro De Equipo (Recall) de Siemens SOMATOM Emotion 6/12 Slice Configuration
  • Tipo de evento
    Recall
  • ID del evento
    16559
  • Fecha de inicio del evento
    2014-04-17
  • 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: Siemens Healthcare (NZ) Ltd, Millennium Centre, Part Level 2, Building A, 600 Great South Road, Ellerslie, AUCKLAND 1051
  • Causa
    Manufcaturer confirms detection of a rubber component with unfavorable ageing properties. the mechanical function of this rubber damper, which is situated within the mounting assembly of the ritation motor, may potentially degrade over time and may impact stability.
  • Acción
    Manufacturer to issue advice regarding use
Retiro De Equipo (Recall) de Siemens SOMATOM Spirit/ Spirit Power
  • Tipo de evento
    Recall
  • ID del evento
    16559
  • Fecha de inicio del evento
    2014-04-17
  • 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: Siemens Healthcare (NZ) Ltd, Millennium Centre, Part Level 2, Building A, 600 Great South Road, Ellerslie, AUCKLAND 1051
  • Causa
    Manufcaturer confirms detection of a rubber component with unfavorable ageing properties. the mechanical function of this rubber damper, which is situated within the mounting assembly of the ritation motor, may potentially degrade over time and may impact stability.
  • Acción
    Manufacturer to issue advice regarding use
Retiro De Equipo (Recall) de Philips MDC PACS Release R2.x and Intellispace PACS DCX R3.x
  • Tipo de evento
    Recall
  • ID del evento
    16562
  • Fecha de inicio del evento
    2014-04-22
  • 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: Philips New Zealand Commercial Limited, Level 3, 123 Carlton Gore Road, Newmarket, AUCKLAND 1023
  • Causa
    Manufacturer has identified a software defect that results in incorrect display of absolute values when measuing pixel density and statistics for region of interest. this issue occurs when enhanced mr and enhanced ct images are sent to the pacs with modality lut (look up tables) as defined in the dicom functional group.
  • Acción
    Software to be upgraded
Retiro De Equipo (Recall) de Hamilton G5 or Hamilton -S1 Ventilator
  • Tipo de evento
    Recall
  • ID del evento
    16566
  • Fecha de inicio del evento
    2014-05-02
  • 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: InterMed Medical Ltd, 71 Apollo Drive, Albany, AUCKLAND 1311
  • Causa
    Investigations have shown that ventilation and aleams of a hamilton-g5 or hamilton-s1 ventilator can be suppressed unintentionally after the activation of a suctioning manoeuvre by the operator; this situation can occur regardless of the selcected patient group (neonatal, pediatric and adult). ventilation must then be manually restarted.
  • Acción
    Product to be modified
Retiro De Equipo (Recall) de Arrow PSI Kits, Multi-Lumen/ PSI Kits, CVC/PSI Kits
  • Tipo de evento
    Recall
  • ID del evento
    16567
  • Fecha de inicio del evento
    2014-04-23
  • 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: InterMed Medical Ltd, 71 Apollo Drive, Albany, AUCKLAND 1311
  • Causa
    Manufacturer is recalling the products die to tip damage noted during internal inspection on the dilator tip of the percutaneous sheath introducer. tip damage has the potential to result in vessel damage.
  • Acción
    Product to be returned to supplier
Retiro De Equipo (Recall) de Biosense ThermoCool SF NAV Uni-directional Catheter
  • Tipo de evento
    Recall
  • ID del evento
    16575
  • Fecha de inicio del evento
    2014-05-23
  • 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: Johnson & Johnson Medical New Zealand Ltd, 507 Mt Wellington Highway, Mt Wellington, AUCKLAND 1060
  • Causa
    The manufacturer has revised the procedural steps and precautions set out in the ifu, 1. when using the devices with conventional systems (using fluroscopy to determine catheter tip location) or with the carto ep navigations system, careful catheter manipulation must be performed in order to avoid cardiac damage, perforation or tamponade., 2. do not use the temperature sensor to monitor tissue temperature., 3. precautionary measures should be taken when ablating on the posterior wall of the left atrium in proximity to the oesophagus to minimse risk of atrio-esophageal fistula.
  • Acción
    Instructions for use to be updated
Retiro De Equipo (Recall) de Biosense ThermoCool SF Nav Bi-Directional Catheter
  • Tipo de evento
    Recall
  • ID del evento
    16575
  • Fecha de inicio del evento
    2014-05-23
  • 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: Johnson & Johnson Medical New Zealand Ltd, 507 Mt Wellington Highway, Mt Wellington, AUCKLAND 1060
  • Causa
    The manufacturer has revised the procedural steps and precautions set out in the ifu, 1. when using the devices with conventional systems (using fluroscopy to determine catheter tip location) or with the carto ep navigations system, careful catheter manipulation must be performed in order to avoid cardiac damage, perforation or tamponade., 2. do not use the temperature sensor to monitor tissue temperature., 3. precautionary measures should be taken when ablating on the posterior wall of the left atrium in proximity to the oesophagus to minimse risk of atrio-esophageal fistula.
  • Acción
    Instructions for use to be updated
Retiro De Equipo (Recall) de Medical Intelligence HexaPOD evo RT Couchtop Securing Screws
  • Tipo de evento
    Recall
  • ID del evento
    16577
  • Fecha de inicio del evento
    2014-04-23
  • 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: Elekta Pty Limited - New Zealand Branch, Level 2, Windsor Court , 128-136 Parnell Road, Parnell, AUCKLAND 1052
  • Causa
    If the screws that secure the hexapod evo rt couchtop are not adequatey tightended during installation, they may loosen over tme. this condition has the following impacts:, 1. there may be incorrect patient respositioning if the hexapod evo rt couchtop is moved., 2. the hexapod evo rt couchtop could tip when a patient is in a highly extended position (which could be the case in treatments of the lower body half).
  • Acción
    Manufacturer to issue advice regarding use
Retiro De Equipo (Recall) de Acumed Tension Band Pin
  • Tipo de evento
    Recall
  • ID del evento
    16594
  • Fecha de inicio del evento
    2014-04-28
  • 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: Ortho Medics Limited, 586 Great South Road, Ellerslie, Auckland 1051
  • Causa
    This implantable product was manufactured wiht a grade of stainless steel that is different than from what was specified. cytotoxicity tests confirm that product is not cytotoxic. additional biocompatibility testing is currently underway. to date there have been no reported injuries and one malfunction with no harm to patient. the root cause of the malfunction is as yet inknown.
  • Acción
    Product to be returned to supplier
Retiro De Equipo (Recall) de Synthes Craniomaxillofacial (CMF) Distraction System, BC Distraction...
  • Tipo de evento
    Recall
  • ID del evento
    16596
  • Fecha de inicio del evento
    2014-05-14
  • 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: Synthes New Zealand Ltd, 507 Mt Wellington Highway, Mt Wellington, Auckland 1060
  • Causa
    The ab and bc distractor bodies used in the craniomaxillofacial distraction system may reverse post-operatively., in the presence of inadequate distraction or reversal of a previously achieved distraction distance, the patient may need to undergo prolonged distraction therapy. in some instances, revision surgery may be needed to replace the device., reversing occurs when the distractor screw is turned in the opposite direction to cause the assembly to lose distraction distance.
  • Acción
    Product to be returned to supplier
Retiro De Equipo (Recall) de Synthes Trauma External Fixation System "MR Conditional"
  • Tipo de evento
    Recall
  • ID del evento
    16597
  • Fecha de inicio del evento
    2014-05-06
  • 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: Synthes New Zealand Ltd, 507 Mt Wellington Highway, Mt Wellington, Auckland 1060
  • Causa
    Labelling changes have been made to synthes external fixation systems (small, medium, large and do) related to mr conditions as a result of changes in required testing protocols to designate a product mr safe, mr conditional, or mr unsafe. metal devices are no longer identified as mr safe and as a result synthes ex-fix systems are no longer labelled mr safe and should be treated as mr conditional.
  • Acción
    Instructions for use to be updated
Retiro De Equipo (Recall) de RaySearch RayStation Radiation therapy treatment planning system 4.0
  • Tipo de evento
    Recall
  • ID del evento
    16598
  • Fecha de inicio del evento
    2014-04-30
  • 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: CARSL Consulting, 50B Puketapu Road, Taradale, Napier 4112
  • Causa
    There is a potential problem with the computation of roi voxel volumes for cases where the ct has variable slice spacing. the dose grid volumetric representation of an roi (region of interest) can be wrong. this affects all dose-volume properties for such rois, including dvh (dose-volume histogram), dose statistics, clinical goals and constraints or objective functions. furthermore, if material override rois are used, or if the external is not represented by contours, the bug can trigger an error in the 3d dose distribution.
  • Acción
    Software to be upgraded
Retiro De Equipo (Recall) de GE Compact Airway Modules E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV and E...
  • Tipo de evento
    Recall
  • ID del evento
    16602
  • Fecha de inicio del evento
    2014-05-01
  • 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: GE Healthcare Limited, 8 Tangihua Street, Auckland 1010
  • Causa
    Loosening of the gas sampling pump hex screw in the module pump unit may lead to pump failure that may cause loss of respiratory airway gas parameter monitoring. if this issue occurs, the monitor will show an alarm note on monitor screen of either "low gas sample flow" or "check sample gas out".
  • Acción
    Product to be modified
Retiro De Equipo (Recall) de Philips Brilliance CT, Ingenuity CT, Ingenuity Core, Ingenuity Core ...
  • Tipo de evento
    Recall
  • ID del evento
    16603
  • Fecha de inicio del evento
    2014-04-30
  • 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: Philips New Zealand Commercial Limited, Level 3, 123 Carlton Gore Road, Newmarket, AUCKLAND 1023
  • Causa
    Philips have found if the service latch is not properly secured during servicing of the device, the table top's subframe becomes free floating causing unintended, horizontal motion., to date, there have been no reported injuries or deaths resulting from this issue.
  • Acción
    Product to be modified
Retiro De Equipo (Recall) de Philips Brilliance CT series and Ingenuity CT series systems
  • Tipo de evento
    Recall
  • ID del evento
    16604
  • Fecha de inicio del evento
    2014-05-01
  • 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: Philips New Zealand Commercial Limited, Level 3, 123 Carlton Gore Road, Newmarket, AUCKLAND 1023
  • Causa
    Philips has determined there are two potential issues that may result in the subframe of the table top becoming free floating and causing unintended, horizontal motion. the two potential issues are:, 1. service latch may not be properly secured, 2. service latch threaded rod may be fractured, to date, there have been no reported injuries or deaths resulting from these issues.
  • Acción
    Product to be modified
Retiro De Equipo (Recall) de Philips Ingenia MR Systems
  • Tipo de evento
    Recall
  • ID del evento
    16992
  • Fecha de inicio del evento
    2014-07-14
  • 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: Philips New Zealand Commercial Limited, Level 3, 123 Carlton Gore Road, Newmarket, AUCKLAND 1023
  • Causa
    In the ingenia rear cover set magnetic m10 nuts (four) were erroneously supplied to the installer instead of a4 stainless steel nuts.
  • Acción
    Product to be modified
Retiro De Equipo (Recall) de StimPod NMS 450 Nerve Stimulator
  • Tipo de evento
    Recall
  • ID del evento
    16612
  • Fecha de inicio del evento
    2014-05-02
  • 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: Anatech Medical Ltd, P O Box 0171, 9 Pirihi Road, Takahiwai, Ruakaka, Whangarei
  • Causa
    In isolated incidences (less than 0.003%) 0 while using the device in nmba monitoring mode, electrodes used may deteriorate to a level where current densities may be large enough to cause superficial burns on the skin of the patient. the occurrence of this phenomena is due to a lack of training on the impedance monitoring fucntion of the device and it is imperative that users are properly trained to monitor the impedance of the electrode/skin impedance through the actual current delivered function in mnba with all stmpof nms450s.
  • Acción
    Instructions for use to be updated
Retiro De Equipo (Recall) de TCVS Terumo/Sarns Disposable Centrifugal Pump
  • Tipo de evento
    Recall
  • ID del evento
    16613
  • Fecha de inicio del evento
    2014-05-01
  • 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: Terumo Australia Pty Ltd (NZ), c/- Healthcare Logistics, 56 Carrington Road, Mount Albert, Auckland 1025
  • Causa
    Manufacturer has received complaints of the sarns disposable centrifugal punps leaking due to a crack in the molded separator. in all but one report, the leaks were discovered during priming of the cardiopulmonary (cpb) circuit and prior to initiating cpb. in these instances the centrifugal pump was successfully changed out with no delays in the surgical procedures., in one report the failure occurred during cpb and the pump was not replaced.
  • Acción
    Product to be returned to supplier
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