Events

Recall of RETCAM SHUTTLE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by CLARITY MEDICAL SYSTEMS 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
    49853
  • Event Risk Class
    II
  • Event Initiated Date
    2012-05-10
  • 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
    Retcam 3 and retcam shuttle devices with v6 software have a software anomaly that causes right eye images to be mislabeled as "left" eye images and or "right" eye images to be mislabeled as "left" eye images when still images are extracted from video recordings. this mislabeling does not occur when an image is captured in still mode. there have been no reported injuries. in the worst case scenario a mislabeled eye image could lead to an error in medical judgement regarding needed intervention.

Device

RETCAM SHUTTLE
  • Model / Serial
    Model Catalog: 20-000100 (Lot serial: n/a); Model Catalog: RETCAM 3 (Lot serial: n/a)
  • Product Description
    RETCAM SHUTTLE
  • Manufacturer
    CLARITY MEDICAL SYSTEMS INC.

Manufacturer

CLARITY MEDICAL SYSTEMS INC.