CARINAsim MAN-1236 Rev 2 and CARINAiso MAN-1237 Rev 2 laser software — Class II medical device recall Z-1709-2014
Terminated recall by LAP of America Laser Applications, LLC, reported 2014-06-11, distributed in AK, AZ, CA, CT, DC, FL, GA, IA…. Potential for patient to be marked incorrectly. Customers currently using CARINAsim or CARINAiso systems can e
| Recall number | Z-1709-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | LAP of America Laser Applications, LLC, Boynton Beach, FL, United States |
| Recall initiated | 2013-10-07 |
| Classified | 2014-06-03 |
| Reported by FDA | 2014-06-11 |
| Terminated | 2016-09-14 |
| Distributed | 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, PR, SC, TN, TX, UT, VA, VT, WA, WY |
| Countries outside the US | BR, CA, CL, CO, HN, MX |
| Quantity | 280 manuals |
| Model numbers | 0007535-0002, 0007536-0001 |
Product
CARINAsim MAN-1236 Rev 2 and CARINAiso MAN-1237 Rev 2 laser software. LAP isocenter marking control software. Laser systems for patient alignment.
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)
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1709-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.