FDA Medical Device Recalls (openFDA)
LAP of America Laser Applications, LLC: CARINAsim MAN-1236 Rev 2 and CARINAiso MAN-1237 Rev 2 laser software. LAP isocenter marking control software. Laser systems for patient alignment.
- Recall number
- Z-1709-2014
- Recalling firm
- LAP of America Laser Applications, LLC
- Product
- CARINAsim MAN-1236 Rev 2 and CARINAiso MAN-1237 Rev 2 laser software. LAP isocenter marking control software. Laser systems for patient alignment.
- Status
- Terminated
- Initiated
- 2013-10-07
- Posted
- 2014-06-03
- Terminated
- 2016-09-14
- 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)
- Root cause
- Software design
- 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.
- Quantity
- 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 the territory of Puerto Rico; and, the countries of Brazil, Canada, Chile, Colombia, Cuba, Honduras, and Mexico.
- Lot, serial or model codes
- CARINAiso = Part # 0007536-0001 CARINAsim = Part #0007535-0002
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- not on file
- Firm FEI
- 1000113153
- Firm city
- Boynton Beach
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28