Events

Recall of SONOSITE M-TURBO ULTRASOUND SYSTEM

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by FUJIFILM SONOSITE 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
    24622
  • Event Risk Class
    II
  • Event Initiated Date
    2011-08-23
  • 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
    During the development process on a research product platform sonosite discovered a data (ratio) display anomaly for a specific calculation within the extended ob/gyn calculation software package. the anomaly exists on the noted m-turbo and micromaxx ultrasound systems when enabled with the extended ob/gyn calculation package. while performing a systolic/diastolic (s/d) ratio measurement if the systolic caliper is repositioned after setting the diastolic cursor the s/d ratio shown at the bottom of the display screen is not updated to reflect the new ratio value (but the correct s/d ratio is printed on patient reports).

Device

SONOSITE M-TURBO ULTRASOUND SYSTEM
  • Model / Serial
    Model Catalog: P08189 (Lot serial: >10 Serial Numbers.); Model Catalog: P08840 (Lot serial: WK02T6); Model Catalog: P08840 (Lot serial: WK037Q); Model Catalog: P08840 (Lot serial: WK03QQ); Model Catalog: P08840 (Lot serial: WK03LN); Model Catalog: P08189 (Lot serial: Contact Manufacturer.)
  • Product Description
    Sonosite M-Turbo Ultrasound System
  • Manufacturer
    FUJIFILM SONOSITE INC.

Manufacturer

FUJIFILM SONOSITE INC.