Events

Recall of SPO2TV PULSE OXIMETER

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by RESPIRONICS NOVAMETRIX LLC.

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
    77643
  • Event Risk Class
    II
  • Event Initiated Date
    1996-04-03
  • 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

Device

SPO2TV PULSE OXIMETER
  • Model / Serial
    Model Catalog: (Lot serial: 85-1971CWX 85-0165BZ); Model Catalog: (Lot serial: 85-016AZ 85-2159CWX); Model Catalog: (Lot serial: 85-0168AZ 85-0318AZX); Model Catalog: (Lot serial: 85-1632CWX 85-1917CWX); Model Catalog: (Lot serial: 93-0356BZWK 85-0174AZ); Model Catalog: (Lot serial: 85-1084CWX 85-0620AZX); Model Catalog: (Lot serial: 85-1466CWX 85-0423AZ); Model Catalog: (Lot serial: 85-1085CWX 85-1945CWX); Model Catalog: (Lot serial: 93-2643BWX 93-0642BWX); Model Catalog: (Lot serial: 85-0314AZ 93-1874BWX); Model Catalog: (Lot serial: 85-1557CWX 85-2077CWX); Model Catalog: (Lot serial: 85-1545CWX 85-1556CWX); Model Catalog: (Lot serial: 85-1534CWX 85-1066CWX); Model Catalog: (Lot serial: 85-1630CWX 85-1611CWX); Model Catalog: (Lot serial: 85-0321AZX 85-1916CWX); Model Catalog: (Lot serial: 93-2642BWX 85-2079CWX); Model Catalog: (Lot serial: 93-1873BWX 85-0173AZ); Model Catalog: (Lot serial: 93-0357BZWK 85-2072CWX); Model Catalog: (Lot serial: 85-2078CWX 85-1558CWX); Model Catalog: (Lot s
  • Manufacturer
    RESPIRONICS NOVAMETRIX LLC

Manufacturer

RESPIRONICS NOVAMETRIX LLC
  • Manufacturer Address
    WALLINGFORD
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    HC