Events

Recall of 90651A SERIES EXPANSION HOUSING PRODUCT OPTIONS *152176

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by SPACELABS HEALTHCARE 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
    152792
  • Event Risk Class
    II
  • Event Initiated Date
    2002-08-08
  • 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
    Air tubing from a nibp monitor may be inadvertently connected to a vascular access such as an in-place patient iv. if air pressure is delivered during such a connection serious injury or death may occur.

Device

90651A SERIES EXPANSION HOUSING PRODUCT OPTIONS *152176
  • Model / Serial
    Model Catalog: 90651A (Lot serial: ); Model Catalog: 90351 (Lot serial: ); Model Catalog: 90426 (Lot serial: ); Model Catalog: 90496 (Lot serial: ); Model Catalog: 90429 (Lot serial: ); Model Catalog: 90430 (Lot serial: ); Model Catalog: 90731 (Lot serial: )
  • Product Description
    NIBP MONITOR FOR MODEL 90651A
  • Manufacturer
    SPACELABS HEALTHCARE INC.

Manufacturer

SPACELABS HEALTHCARE INC.
  • Manufacturer Address
    SNOQUALMIE
  • Source
    HC