CARINAsim MAN-1236 Rev 2 and CARINAiso MAN-1237 Rev 2 laser software. LAP isocenter marking control software. Laser syst

FDA device recall Z-1709-2014 · posted 2014-06-03 · Terminated

Recall details

Recalling firm

LAP of America Laser Applications, LLC

Reason for recall

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 taken

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.

Root cause

Software design

Status

Terminated

Quantity affected

280 Manuals

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 th

Date initiated

2013-10-07

Date posted

2014-06-03

Date terminated

2016-09-14

Location

Boynton Beach, FL