Events

Recall of IS3000 HD Lamp Modules with metal finish (endoscopic illumination system used with the da Vinci Si Vision Cart System which is a robotic surgical system)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Device Technologies Australia 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-2013-RN-01127-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-11-12
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01127-1
  • 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
    The manufacturer, intuitive surgical has identified that the metalized coating on the is3000 hd lamp module (pn ins-950093-05) may be incompatible with the illuminator (pn ins-951183-06) control board, leading to a red preventive maintenance advisory (pma) that shows up on all monitors and cannot be dismissed by the user. in rare circumstances the illuminator may be damaged or the lamp module might not illuminate. there have been no reports of lamp failures associated with this issue.
  • Action
    Device Technologies is advising users that this issue does not affect lamps with plastic coating. Affected lamps with metal finish may continue to be used until a replacement is received. If an error message is displayed, users should contact their Device Technologies representative.

Device

IS3000 HD Lamp Modules with metal finish (endoscopic illumination system used with the da Vinci S...
  • Model / Serial
    IS3000 HD Lamp Modules with metal finish (endoscopic illumination system used with the da Vinci Si Vision Cart System which is a robotic surgical system)Part Number (PN): INS-950093-05ARTG Number: 97348
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd