LAP of America Laser Applications, LLC: Medical Device Recall in 2014 - (Recall #: Z-1709-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: October 7, 2013

Date Posted: June 11, 2014

Recall Number: Z-1709-2014

Event ID: 68266

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)

Status: Terminated

Product Quantity: 280 Manuals

Code Information:

CARINAiso = Part # 0007536-0001 CARINAsim = Part #0007535-0002

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated