Events

Recall of CARINAsim and CARINAiso

According to U.S. Food and Drug Administration, this recall involved a device in United States 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
    68266
  • Event Risk Class
    Class 2
  • Event Number
    Z-1709-2014
  • Event Initiated Date
    2013-10-07
  • Event Date Posted
    2014-06-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-09-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127241
  • 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
  • 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).
  • Action
    On 10/16/2013 Customers were sent an Urgent field safety notice for Corrective action concerning the operating instructions of CARINAsim and CARINAiso. The letter identified the affected product, as well as the issues involved. Users were to review their current operating steps and validate their operating sequence. Users should have received a modified software version with software update in February 2014. All users should have been notified of this letter and a copy should be maintained in the users' records. Questions should be directed to Thomas Gaudet on 561-416-9250 at the Service Center.

Device

CARINAsim and CARINAiso
  • Model / Serial
    CARINAiso = Part # 0007536-0001  CARINAsim = Part #0007535-0002
  • Distribution
    Worldwide Distribution -- USA, including the states of AK, AZ, CA, CT, DC, FL, GA, IA, ID, IL, KS, LA, MA, MD, MI, MN, MO, MS, NC, NH, NJ, NM, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WY and the territory of Puerto Rico; and, the countries of Brazil, Canada, Chile, Colombia, Cuba, Honduras, and Mexico.
  • Product Description
    CARINAsim MAN-1236 Rev 2 and CARINAiso MAN-1237 Rev 2 laser software. LAP isocenter marking control software. Laser systems for patient alignment.
  • Manufacturer
    LAP of America Laser Applications, LLC

Manufacturer

LAP of America Laser Applications, LLC
  • Manufacturer Address
    LAP of America Laser Applications, LLC, 161 Commerce Rd Ste 3, Boynton Beach FL 33426-9385
  • Source
    USFDA