Events

Recall of ACUSON P50 DIAGNOSTIC ULTRASOUND SYSTEM - MAIN UNIT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by SIEMENS CANADA LIMITED - HEALTHCARE.

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
    18467
  • Event Risk Class
    III
  • Event Initiated Date
    2009-07-02
  • 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
    1)in versions 1.1 and 1.1 the needle guide feature was to be disabled for all transducers but actually actived for 12l5 transducer. 2)in non-cardiac application can be an error in estimation of velocity when using pi tool which is sensitive to noise in spectral doppler waveform causing mis-trace user is unaware of miscalculations.

Device

ACUSON P50 DIAGNOSTIC ULTRASOUND SYSTEM - MAIN UNIT
  • Model / Serial
    Model Catalog: 10041762 (Lot serial: 10120); Model Catalog: 10041762 (Lot serial: 10122)
  • Product Description
    ACUSON P50 DIAGNOSTIC ULTRASOUND SYSTEM
  • Manufacturer
    SIEMENS CANADA LIMITED - HEALTHCARE

Manufacturer

SIEMENS CANADA LIMITED - HEALTHCARE
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    HC