Events

Recall of CARESTREAM DRX-1 SYSTEM DETECTOR

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by CARESTREAM HEALTH CANADA COMPANY.

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
    47353
  • Event Risk Class
    II
  • Event Initiated Date
    2012-06-21
  • 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
    Two occurrences of lithium-ion battery overheating have come to carestream's attention. the overheating caused the plastic battery casing of the drx detector to melt which can cause burns or other injury.

Device

CARESTREAM DRX-1 SYSTEM DETECTOR
  • Model / Serial
    Model Catalog: 154 3834 (Lot serial: prior to June 2012); Model Catalog: 154 3834 (Lot serial: All Batteries with mfg date)
  • Product Description
    CARESTREAM DRX-1 SYSTEM BATTERIES
  • Manufacturer
    CARESTREAM HEALTH CANADA COMPANY

Manufacturer

CARESTREAM HEALTH CANADA COMPANY
  • Manufacturer Address
    VAUGHAN
  • Manufacturer Parent Company (2017)
    ONEX Corp
  • Source
    HC