Events

Recall of ARIATELE TELEMETRY TRANSMITTER (FOR USE WITH SPACELABS HEALTHCARE ULTRAVIEW MONITOR & RECEIVER)

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by SPACELABS HEALTHCARE (CANADA) 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
    131436
  • Event Risk Class
    II
  • Event Initiated Date
    2014-01-09
  • 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
    The ariatele (transmitter) display and the telemetry central station display may show a spo2 value when the sensor is not connected to the patient or in certain sensor failed conditions. no one has been injured as a result of this issue.

Device

ARIATELE TELEMETRY TRANSMITTER (FOR USE WITH SPACELABS HEALTHCARE ULTRAVIEW MONITOR & RECEIVER)
  • Model / Serial
    Model Catalog: 96281-C (Lot serial: > 10 lot numbers contact mfg)
  • Product Description
    AriaTele Telemetry Transmitter
  • Manufacturer
    SPACELABS HEALTHCARE (CANADA) INC.

Manufacturer

SPACELABS HEALTHCARE (CANADA) INC.
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    OSI Systems Inc
  • Source
    HC