Events

Recall of da Vinci Xi Surgical System P6b Software

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-2017-RN-01543-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2018-01-04
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01543-1
  • 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
    Device technologies has learned from the manufacturer, intuitive surgical, that the updated da vinci xi surgical system user manual and the updated da vinci xi instrument and accessory user manual were not provided when the system upgrade was performed. the user manuals will be forwarded to affected customers.
  • Action
    1. Device Technologies Australia will forward the updated manuals to affected customers. Once the updated System User Manual and the updated Instruments & Accessories User Manual have been received, disregard the previous versions of the system User Manual and the Instruments & Accessories User Manual. 2. Ensure all relevant personnel at your facility are fully informed of this notice, including medical staff who perform da Vinci® XiTM Surgery procedures. 3. Complete and return the supplied Reply Form to acknowledge receipt of this notice. 4. Retain a copy of this letter and the acknowledgement form within the updated System User Manual and the updated Instruments & Accessories User Manual of the da Vinci® XiTM System.

Device

da Vinci Xi Surgical System P6b Software

Manufacturer

Device Technologies Australia Pty Ltd