Events

Recall of VOLISTA

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by MAQUET-DYNAMED INC..

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
    62903
  • Event Risk Class
    II
  • Event Initiated Date
    2018-01-05
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Extra notes in the data
  • Reason
    There is a possibility that the central handle holder detaches from the cupola during use. we determined that the root cause of this malfunction is excessive tightening of the screws during mounting of the handle holder resulting in the rivets loosening and detaching from the central handle holder ring. there is a remote chance that this issue may cause post-operative infection foreign body granuloma or allergic reactions if the particles fall into the patient's wound or on sterile equipment.

Device

VOLISTA
  • Model / Serial
    Model Catalog: ARD568821961 (Lot serial: >10numbers contact mfg); Model Catalog: ARD568821960 (Lot serial: >10numbers contact mfg); Model Catalog: ARD568812963 (Lot serial: >10numbers contact mfg); Model Catalog: ARD568812952 (Lot serial: >10numbers contact mfg); Model Catalog: ARD568812913 (Lot serial: >10numbers contact mfg); Model Catalog: ARD568811903 (Lot serial: >10numbers contact mfg); Model Catalog: ARD568811963 (Lot serial: >10numbers contact mfg); Model Catalog: ARD568811961 (Lot serial: >10numbers contact mfg); Model Catalog: ARD568811952 (Lot serial: >10numbers contact mfg); Model Catalog: ARD568811913 (Lot serial: >10numbers contact mfg); Model Catalog: ARD568811912 (Lot serial: >10numbers contact mfg); Model Catalog: ARD568812912 (Lot serial: >10numbers contact mfg)
  • Product Description
    Volista Surgical Lights
  • Manufacturer
    MAQUET-DYNAMED INC.

Manufacturer

MAQUET-DYNAMED INC.
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    HC