Events

Recall of GE D-Fend & D-Fend+ Water Traps

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by GE Healthcare Finland Oy.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    18454
  • Event Initiated Date
    2015-04-30
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    Recalling Organisation: GE Healthcare Limited, 8 Tangihua Street, Auckland 1010
  • Reason
    Occlusion of specific lots of d-fend/d-fend+ water traps could occur immediately after replacement. this water trap occlusion could cause a loss of respiratory airway gas monitoring. when this issue is detected the connected monitoring device will issue an audio alarm and display "low gas sample flow", "replace water trap" or "sampling line blocked" warning messages. unattended or prolonged warnings could lead to an adverse clinical situation if the co2 value would rapidly change in certain clinical conditions.
  • Action
    Product to be destroyed

Device

GE D-Fend & D-Fend+ Water Traps
  • Model / Serial
    Model: Part Numbers: 876446-HEL (D-Fend), 881319-HEL (D-Fend+), Affected: Lots: J9964985, J10201698, J10258248, J10284871, J10284872, J10344108 (D-Fend); J9906966, J9965152, J10258251, J10300071 (D-Fend+)
  • Manufacturer
    GE Healthcare Finland Oy

Manufacturer

GE Healthcare Finland Oy