Events

Recall of ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM - ABVS SYSTEM

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

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
    104809
  • Event Risk Class
    II
  • Event Initiated Date
    2013-01-23
  • 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
    On some acuson s2000 systems with abvs options the edges on the inside of the transducer pod may not be competely deburred to avoid sharp edges. a potential risk exists that an operator could sustain a cut when touching the sharp edge while cleaning the inside of the pod.

Device

ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM - ABVS SYSTEM
  • Model / Serial
    Model Catalog: 10434730 (Lot serial: SERIAL NUMBER 203516)
  • Product Description
    ACUSON S2000 ABVS SYSTEM
  • Manufacturer
    SIEMENS HEALTHCARE LIMITED

Manufacturer

SIEMENS HEALTHCARE LIMITED
  • Manufacturer Address
    OAKVILLE
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    HC