Events

Recall of MicroGas 7650 Operator Manual used with Radiometer MicroGas 7650 Transcutaneous Monitor

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Radiometer Pacific Pty Ltd.

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
    RC-2015-RN-00617-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-07-09
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00617-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    Radiometer has recently become aware that the storage temperature range for the combi m sensor 82 printed in the operators manual for microgas 7650 is incorrect. the operators manual states that the storage temperature range is -40c to +70c when it should be -10c to +50c as per the information supplied with the product.
  • Action
    Radiometer is reiterating instructions on how to verify the performance of the sensor. An addendum to the instructions for use is also being provided with the correct storage conditions. This action has been closed-out on 15/08/2016.

Device

MicroGas 7650 Operator Manual used with Radiometer MicroGas 7650 Transcutaneous Monitor
  • Model / Serial
    MicroGas 7650 Operator Manual used with Radiometer MicroGas 7650 Transcutaneous MonitorSerial Numbers: All lotsAffects: COMBI M sensor 82 ; Item code: 0605000ARTG Number: 140334
  • Manufacturer
    Radiometer Pacific Pty Ltd

Manufacturer

Radiometer Pacific Pty Ltd