Events

Recall of CARINAISO LASER MARKING SOFTWARE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by LAP OF AMERICA LASER APPLICATIONS 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
    69293
  • Event Risk Class
    II
  • Event Initiated Date
    2013-11-08
  • 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
    Potential for patient to be marked incorrectly. customers currently using carinasim or carinaiso systems can encounter two safety relevant errors in the operating instructions (carinasim man-1236 rev 2 / carinaiso man-1237 rev 2).

Device

CARINAISO LASER MARKING SOFTWARE
  • Model / Serial
    Model Catalog: COM-00115 (Lot serial: CARINAiso.1.1.3.MAN-1237Ver2.0); Model Catalog: COM-00126 (Lot serial: CARINAsim.1.1.3.MAN-1237Ver2.0)
  • Product Description
    CARINAiso Laser Marking System
  • Manufacturer
    LAP OF AMERICA LASER APPLICATIONS LLC

Manufacturer

LAP OF AMERICA LASER APPLICATIONS LLC