CARINAsim MAN-1236 Rev 2 and CARINAiso MAN-1237 Rev 2 laser software. LAP isocenter marking contr...
FDA Device Recall #Z-1709-2014 — Class II — October 7, 2013
Recall Summary
| Recall Number | Z-1709-2014 |
| Classification | Class II — Moderate risk |
| Date Initiated | October 7, 2013 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | LAP of America Laser Applications, LLC |
| Location | Boynton Beach, FL |
| Product Type | Devices |
| Quantity | 280 Manuals |
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.
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)
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.
Lot / Code Information
CARINAiso = Part # 0007536-0001 CARINAsim = Part #0007535-0002
Other Recalls from LAP of America Laser Applications, LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1866-2014 | Class II | LAP LASER PICTOR 3D Multi Color Laser System P... | Mar 21, 2014 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.