Recall of MATRX PLUS SYSTEM KIT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by ZEPHYR SLEEP TECHNOLOGIES.

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
    153412
  • Event Risk Class
    III
  • Event Initiated Date
    2017-07-19
  • Event Country
  • 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
    Internal quality control found that the matrx plus may incorrectly position the mandible during a test up to 2mm. the device's functional check may also allow the device to be used with a positional inaccuracy of up to 0.5mm.

Device

  • Model / Serial
    Model Catalog: CAT-001-01 (Lot serial: Tablet S/N: E170016); Model Catalog: CAT-001-01 (Lot serial: Tablet S/N: E170003 to E170013); Model Catalog: CAT-001-01 (Lot serial: MP S/N: C170003 to C170013); Model Catalog: CAT-001-01 (Lot serial: MP S/N: C170017 to C170018); Model Catalog: CAT-001-01 (Lot serial: MP S/N/: C170020); Model Catalog: CAT-001-01 (Lot serial: Tablet S/N: E170015)
  • Product Description
    MATRx plus
  • Manufacturer

Manufacturer