Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
CARINAsim MAN-1236 Rev 2 and CARINAiso MAN-1237 Rev 2 laser Recalled by LAP of America Laser Applications, LLC Due to Potential for patient to be marked incorrectly. Customers...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact LAP of America Laser Applications, LLC directly.
Affected Products
CARINAsim MAN-1236 Rev 2 and CARINAiso MAN-1237 Rev 2 laser software. LAP isocenter marking control software. Laser systems for patient alignment.
Quantity: 280 Manuals
Why Was This Recalled?
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)
Where Was This Sold?
This product was distributed to 35 states: AK, AZ, CA, CT, FL, GA, ID, IL, IA, KS, LA, MD, MA, MI, MN, MS, MO, NH, NJ, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, UT, VT, VA, WA, WY, DC
About LAP of America Laser Applications, LLC
LAP of America Laser Applications, LLC has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report