Events

Recall of CME Bodyguard Ambulatory Infusion System

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Caesarea Medical Electronics Ltd (Israel).

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
    13770
  • Event Initiated Date
    2012-11-08
  • 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: REM Systems Limited, 69 Elizabeth Knox Place, Glen Innes, AUCKLAND
  • Reason
    The manufacturer has issued a software upgrade for the cme pumps to addresses the issue of under infusion by instructing the pump mechanism to move to the nearest optimum resting position for the pumping fingers once the bolus has been given.
  • Action
    Software to be upgraded

Device

CME Bodyguard Ambulatory Infusion System

Manufacturer

Caesarea Medical Electronics Ltd (Israel)