Events

Recall of MX Series Products

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Wescam 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
    53809
  • Event Risk Class
    Class 2
  • Event Number
    Z-0172-2010
  • Event Initiated Date
    2009-08-01
  • Event Date Posted
    2009-12-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-01-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86563
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Laser Target Designator - Product Code RET
  • Reason
    Products do not comply with 21 cfr 1040.11.
  • Action
    L-3 Wescam has issued notification of the MX Series Products describing a non-compliance with 1040.11(b). The notice instructs customers to refrain from using the infrared laser illuminator, based on a serious eye hazard from viewing the direct or reflected laser emission. Products will be repaired or removed if they cannot be repaired and a refund will be implemented.

Device

MX Series Products
  • Model / Serial
    Only model numbers.
  • Device Class
    Not Classified
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    MX Series Products, Model numbers MX 20, MX 20 High Definition (HD), MX 15, MX 15i (integrated) and MX 15 HDi. || Long range surveillance, target designation.
  • Manufacturer
    Wescam Inc

Manufacturer

Wescam Inc
  • Manufacturer Address
    Wescam Inc, 649 North Service Road West, Burlington Canada Ontario
  • Manufacturer Parent Company (2017)
    L3 Technologies Inc.
  • Source
    USFDA